Manufacturer's Devices - Coloplast AS

Address:




Holtedam 1



Humlebaek

3050

Denmark


Authorised Representative/ UK Responsible Person
Name: Coloplast Ltd
Address:

Nene Hall Peterborough Business Park



Peterborough

Cambridgeshire PE2 6FX

England United Kingdom




Code/Term Type
Exudate-absorbent dressing non-gel non-antimicrobialExudate-absorbent dressing non-gel non-antimicrobialClass III
Antimicrobial skin friction/moisture control fabric single-patient reusableAntimicrobial skin friction/moisture control fabric single-patient reusableClass III
Indwelling urethral drainage balloon catheter non-antimicrobialIndwelling urethral drainage balloon catheter non-antimicrobialClass IIb
Inflatable penile prosthesisInflatable penile prosthesisClass IIb
Rigid penile prosthesisRigid penile prosthesisClass IIb
Polymeric ureteral stentPolymeric ureteral stentClass IIb
Anal plug single-useAnal plug single-useClass IIb
Exudate-absorbent dressing hydrophilic-gel non-antimicrobialExudate-absorbent dressing hydrophilic-gel non-antimicrobialClass IIb
Intestinal stoma shield/support belt single-useIntestinal stoma shield/support belt single-useClass IIb
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass IIa
Colostomy rodColostomy rodClass IIa
Wound hydrogel dressing non-antimicrobialWound hydrogel dressing non-antimicrobialClass IIb
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass IIa
Nephrostomy sheathNephrostomy sheathClass IIa
General-purpose endoscopic needle single-useGeneral-purpose endoscopic needle single-useClass IIa
Biliary/urinary stone retrieval basket single-useBiliary/urinary stone retrieval basket single-useClass IIa
Urinary stone retrieval basket single-useUrinary stone retrieval basket single-useClass IIa
Surgical irrigation/aspiration cannula non-illuminating single-useSurgical irrigation/aspiration cannula non-illuminating single-useClass IIa
Stoma drainage catheterStoma drainage catheterClass IIa
Polymeric ureteral stentPolymeric ureteral stentClass IIa
Closed-wound drain non-bioabsorbableClosed-wound drain non-bioabsorbableClass IIa
Indwelling urethral drainage balloon catheter non-antimicrobialIndwelling urethral drainage balloon catheter non-antimicrobialClass IIa
Suprapubic drainage catheterSuprapubic drainage catheterClass IIb
Gastrointestinal motility manometric catheter non-electronicGastrointestinal motility manometric catheter non-electronicClass IIa
Urodynamic measurement systemUrodynamic measurement systemClass IIa
Donor-organ perfusion catheterDonor-organ perfusion catheterClass IIa
Surgical capillary wound drain luminal Hevea-latexSurgical capillary wound drain luminal Hevea-latexClass IIa
Pleural catheterPleural catheterClass IIa
Biliary drainBiliary drainClass IIa
Non-ISO80369-standardized small-bore multichannel connectorNon-ISO80369-standardized small-bore multichannel connectorClass IIa
Ureteral sheathUreteral sheathClass IIa
Indwelling urethral drainage balloon catheter non-antimicrobialIndwelling urethral drainage balloon catheter non-antimicrobialClass IIa
Suction system catheter general-purposeSuction system catheter general-purposeClass IIa
Indwelling urethral drainage balloon catheter non-antimicrobialIndwelling urethral drainage balloon catheter non-antimicrobialClass IIb
Suprapubic drainage catheterSuprapubic drainage catheterClass IIb
Polymeric ureteral stentPolymeric ureteral stentClass IIb
Stoma drainage catheterStoma drainage catheterClass IIb
Ureteral catheterUreteral catheterClass IIa
Gastro-urological guidewire single-useGastro-urological guidewire single-useClass IIa
Nephrostomy catheter introduction needleNephrostomy catheter introduction needleClass IIa
Nephrostomy catheterNephrostomy catheterClass IIa
Exudate-absorbent dressing non-gel non-antimicrobialExudate-absorbent dressing non-gel non-antimicrobialClass IIb
Endoscopic-access dilator single-useEndoscopic-access dilator single-useClass IIa
Nephrostomy catheterNephrostomy catheterClass IIb
Urethral/suprapubic catheter valve-connectorUrethral/suprapubic catheter valve-connectorClass I
Oesophageal bougie single-useOesophageal bougie single-useClass I
Closed-wound/centesis drainage receptacleClosed-wound/centesis drainage receptacleClass I
Urological catheter stylet transurethralUrological catheter stylet transurethralClass I
Inflatable penile prosthesisInflatable penile prosthesisClass I
Urethral bougie single-useUrethral bougie single-useClass I
Ureteral catheterUreteral catheterClass I
Endoscopic-access dilator single-useEndoscopic-access dilator single-useClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Single-administration urethral drainage catheterSingle-administration urethral drainage catheterClass I
Single-administration urethral drainage catheterSingle-administration urethral drainage catheterClass I
Single-administration urethral catheterization kit single-useSingle-administration urethral catheterization kit single-useClass I
Wearable adult urine collection bag open-endedWearable adult urine collection bag open-endedClass I
Non-wearable adult urine collection bag open-endedNon-wearable adult urine collection bag open-endedClass I
Non-wearable adult urine collection bag open-endedNon-wearable adult urine collection bag open-endedClass I
Wound debridement padWound debridement padClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Non-wearable adult urine collection bag open-endedNon-wearable adult urine collection bag open-endedClass I
Manual rectal irrigation systemManual rectal irrigation systemClass I
Rectal irrigation kitRectal irrigation kitClass I
Manual rectal irrigation systemManual rectal irrigation systemClass I
Rectal irrigation system catheterRectal irrigation system catheterClass I
Rectal irrigation kitRectal irrigation kitClass I
Rectal/colonic lavage support kitRectal/colonic lavage support kitClass I
Gastro-urological stoma leak detection systemGastro-urological stoma leak detection systemClass I
Gastro-urological stoma leak detection system sensorGastro-urological stoma leak detection system sensorClass I
Skin moisture barrier dressingSkin moisture barrier dressingClass I
Secretion/excreta skin cleanserSecretion/excreta skin cleanserClass I
Multiple-piece intestinal ostomy bag closed-endedMultiple-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
Multiple-piece intestinal ostomy bag closed-endedMultiple-piece intestinal ostomy bag closed-endedClass I
Multiple-piece intestinal ostomy bag closed-endedMultiple-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
Multiple-piece intestinal ostomy bag closed-endedMultiple-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
Multiple-piece intestinal ostomy bag closed-endedMultiple-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
Multiple-piece intestinal ostomy bag closed-endedMultiple-piece intestinal ostomy bag closed-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
Intestinal ostomy base plate convexIntestinal ostomy base plate convexClass I
Intestinal ostomy base plate convexIntestinal ostomy base plate convexClass I
Intestinal ostomy base plate concaveIntestinal ostomy base plate concaveClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
Intestinal ostomy base plate convexIntestinal ostomy base plate convexClass I
Intestinal ostomy base plate convexIntestinal ostomy base plate convexClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
Intestinal ostomy base plate convexIntestinal ostomy base plate convexClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
Intestinal ostomy base plate convexIntestinal ostomy base plate convexClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Intestinal ostomy base plate convexIntestinal ostomy base plate convexClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Ostomy odour-absorbent/deodorizerOstomy odour-absorbent/deodorizerClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Ostomy bag pressure bandageOstomy bag pressure bandageClass I
Ostomy bag pressure bandageOstomy bag pressure bandageClass I
Patient medical adhesive removerPatient medical adhesive removerClass I
Patient medical adhesive removerPatient medical adhesive removerClass I
Patient medical adhesive removerPatient medical adhesive removerClass I
Synthetic-polymer liquid barrier dressing non-sterileSynthetic-polymer liquid barrier dressing non-sterileClass I
Synthetic-polymer liquid barrier dressing non-sterileSynthetic-polymer liquid barrier dressing non-sterileClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
Pressure bandage non-latex single-usePressure bandage non-latex single-useClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Pressure bandage non-latex single-usePressure bandage non-latex single-useClass I
Urinary incontinence penis sheath/port single-useUrinary incontinence penis sheath/port single-useClass I
Urinary incontinence penis sheath/port single-useUrinary incontinence penis sheath/port single-useClass I
Urinary incontinence penis sheath/port single-useUrinary incontinence penis sheath/port single-useClass I
Urinary incontinence penis sheath/port single-useUrinary incontinence penis sheath/port single-useClass I
Urinary incontinence penis sheath/port single-useUrinary incontinence penis sheath/port single-useClass I
Urinary catheter holderUrinary catheter holderClass I
Non-wearable adult urine collection bag closed-endedNon-wearable adult urine collection bag closed-endedClass I
Manual rectal irrigation systemManual rectal irrigation systemClass I
Rectal irrigation system catheterRectal irrigation system catheterClass I
Rectal irrigation kitRectal irrigation kitClass I
Rectal/colonic lavage support kitRectal/colonic lavage support kitClass I
Wearable adult urine collection bag open-endedWearable adult urine collection bag open-endedClass I
Wearable adult urine collection bag open-endedWearable adult urine collection bag open-endedClass I
Wearable adult urine collection bag open-endedWearable adult urine collection bag open-endedClass I
Wearable adult urine collection bag open-endedWearable adult urine collection bag open-endedClass I
Wearable adult urine collection bag open-endedWearable adult urine collection bag open-endedClass I
Non-wearable adult urine collection bag closed-endedNon-wearable adult urine collection bag closed-endedClass I
Personal device holder reusablePersonal device holder reusableClass I
Personal device holder reusablePersonal device holder reusableClass I
Non-wearable urine/faecal collection bag holderNon-wearable urine/faecal collection bag holderClass I
Non-wearable urine/faecal collection bag holderNon-wearable urine/faecal collection bag holderClass I
Non-wearable urine/faecal collection bag holderNon-wearable urine/faecal collection bag holderClass I
Peristomal/periwound dressingPeristomal/periwound dressingClass I
Urethral self-catheterization assistive handleUrethral self-catheterization assistive handleClass I
Ostomy bag closure deviceOstomy bag closure deviceClass I
Multiple-piece urostomy bag open-endedMultiple-piece urostomy bag open-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
One-piece urostomy bag open-endedOne-piece urostomy bag open-endedClass I
Colostomy irrigation kit reusableColostomy irrigation kit reusableClass I
Colostomy irrigation sleeveColostomy irrigation sleeveClass I
Colostomy irrigation bagColostomy irrigation bagClass I
Colonic lavage nozzle non-sterile reusableColonic lavage nozzle non-sterile reusableClass I
Ostomy appliance ring/beltOstomy appliance ring/beltClass I
Synthetic-polymer liquid barrier dressing non-sterileSynthetic-polymer liquid barrier dressing non-sterileClass I
Synthetic-polymer liquid barrier dressing non-sterileSynthetic-polymer liquid barrier dressing non-sterileClass I
Urological surgical procedure kit non-medicated single-useUrological surgical procedure kit non-medicated single-use
Male stress urinary incontinence surgical mesh-sling synthetic polymerMale stress urinary incontinence surgical mesh-sling synthetic polymerClass IIb
Luer/non-ISO80369-standardized linear connector single-useLuer/non-ISO80369-standardized linear connector single-useClass I
Non-ISO80369-standardized small-bore linear connector single-useNon-ISO80369-standardized small-bore linear connector single-useClass I
Urinary incontinence penis sheath/port single-useUrinary incontinence penis sheath/port single-useClass I
Multiple-piece intestinal ostomy bag closed-endedMultiple-piece intestinal ostomy bag closed-endedClass I
Multiple-piece intestinal ostomy bag open-endedMultiple-piece intestinal ostomy bag open-endedClass I
Intestinal ostomy base plate flatIntestinal ostomy base plate flatClass I
One-piece intestinal ostomy bag closed-endedOne-piece intestinal ostomy bag closed-endedClass I
One-piece intestinal ostomy bag open-endedOne-piece intestinal ostomy bag open-endedClass I
Exudate-absorbent dressing non-gel antimicrobialExudate-absorbent dressing non-gel antimicrobial Conformity Assessment Certificate ExpiredClass III
Cavity-wound management dressing non-antimicrobialCavity-wound management dressing non-antimicrobial Conformity Assessment Certificate ExpiredClass III
Exudate-absorbent dressing non-gel antimicrobialExudate-absorbent dressing non-gel antimicrobialClass III