Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Bfactory Health Products B.V.

Address:

Remmerden 58

Rhenen

3911 TZ

Netherlands

Authorised Representative/ UK Responsible Person
Name: Oswell Penda Pharmaceutical LTD
Address:

14 Park Drive

Oswestry

Shropshire SY11 1BW

England United Kingdom

Code/Term Type

Collagen wound matrix dressing Collagen wound matrix dressing Class III

Skin osmotic dressing antimicrobial Skin osmotic dressing antimicrobial Conformity Assessment Certificate Expired Class IIa

Wound-nonadherent dressing permeable antimicrobial Wound-nonadherent dressing permeable antimicrobial Conformity Assessment Certificate Expired Class IIb

Exudate-absorbent dressing hydrophilic-gel antimicrobial Exudate-absorbent dressing hydrophilic-gel antimicrobial Conformity Assessment Certificate Expired Class IIb

Exudate-absorbent dressing hydrophilic-gel antimicrobial Exudate-absorbent dressing hydrophilic-gel antimicrobial Conformity Assessment Certificate Expired Class IIb

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Collagen wound matrix dressing	Collagen wound matrix dressing	Class III
Skin osmotic dressing antimicrobial	Skin osmotic dressing antimicrobial Conformity Assessment Certificate Expired	Class IIa
Wound-nonadherent dressing permeable antimicrobial	Wound-nonadherent dressing permeable antimicrobial Conformity Assessment Certificate Expired	Class IIb
Exudate-absorbent dressing hydrophilic-gel antimicrobial	Exudate-absorbent dressing hydrophilic-gel antimicrobial Conformity Assessment Certificate Expired	Class IIb
Exudate-absorbent dressing hydrophilic-gel antimicrobial	Exudate-absorbent dressing hydrophilic-gel antimicrobial Conformity Assessment Certificate Expired	Class IIb