Manufacturer's Devices - Roche Diabetes Care Gmbh

Address:




Sandhofer Strasse 116



Mannheim

68305

Germany


Authorised Representative/ UK Responsible Person
Name: Roche Diabetes Care Ltd.
Address:

Charles Avenue Burgess Hill RH15 9RY



Burgess Hill

RH15 9RY

United Kingdom




Code/Term Type
Manual blood lancing device reusableManual blood lancing device reusableClass IIa
Partially-implantable abdominal port/catheterPartially-implantable abdominal port/catheterClass IIb
Electric infusion pump administration set single-useElectric infusion pump administration set single-useClass IIa
Insulin infusion cannula introducerInsulin infusion cannula introducerClass I
Ambulatory insulin infusion administration set/reservoir kitAmbulatory insulin infusion administration set/reservoir kitClass IIb
Ambulatory insulin infusion pump remote control/blood glucose analyserAmbulatory insulin infusion pump remote control/blood glucose analyserClass IIb
Ambulatory insulin infusion pump reservoirAmbulatory insulin infusion pump reservoirClass IIa
Ambulatory insulin infusion pump electronic non-software-dosingAmbulatory insulin infusion pump electronic non-software-dosingClass IIb
Home healthcare information system application softwareHome healthcare information system application softwareClass I
Home healthcare information systemHome healthcare information systemClass I
Home healthcare information system application softwareHome healthcare information system application softwareClass IIb
Self-care monitoring/reporting softwareSelf-care monitoring/reporting softwareClass IIb
Manual blood lancing device reusableManual blood lancing device reusableClass I
Self-care monitoring/reporting softwareSelf-care monitoring/reporting softwareClass I
Electric infusion pump administration set single-useElectric infusion pump administration set single-useClass IIb
Blood lancing device tipBlood lancing device tipClass IIa
Manual blood lancing device single-useManual blood lancing device single-useClass IIa
Glucose IVD reagentGlucose IVD reagentIVD Annex II List B
Glucose IVD controlGlucose IVD controlIVD Annex II List B
Glucose monitoring system IVD home-useGlucose monitoring system IVD home-useIVD Annex II List B
Ambulatory insulin infusion pump/blood glucose analyser systemAmbulatory insulin infusion pump/blood glucose analyser systemClass IIb
Ambulatory insulin infusion administration setAmbulatory insulin infusion administration setClass IIb