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 - Xuchang Zhende Surgical Dressing Co. Ltd.

Address:

1 Jinhui Road Industry Cluster District

Yanling County Yanling County

461200 Xuchang

Henan Province 461200

China

Authorised Representative/ UK Responsible Person
Name: Rocialle Healthcare Limited
Address:

Cwm Cynon Business Park

Mountain Ash

Rhondda CF45 4ER

United Kingdom

Code/Term Type

Radiopaque woven surgical sponge Radiopaque woven surgical sponge Class I

Radiopaque non-woven surgical sponge Radiopaque non-woven surgical sponge Class IIa

Woven gauze pad Woven gauze pad Class IIa

Surgical/medical face mask single-use Surgical/medical face mask single-use Class I

Antiseptic towelette Antiseptic towelette Class I

Cotton wool ball Cotton wool ball Class I

General-purpose medical fibre padding General-purpose medical fibre padding Class I

Non-woven gauze pad Non-woven gauze pad Class I

Wound dressing kit non-medicated Wound dressing kit non-medicated Class I

Wound dressing kit non-medicated Wound dressing kit non-medicated Class I

Wound dressing kit non-medicated Wound dressing kit non-medicated Class IIa

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
Radiopaque woven surgical sponge	Radiopaque woven surgical sponge	Class I
Radiopaque non-woven surgical sponge	Radiopaque non-woven surgical sponge	Class IIa
Woven gauze pad	Woven gauze pad	Class IIa
Surgical/medical face mask single-use	Surgical/medical face mask single-use	Class I
Antiseptic towelette	Antiseptic towelette	Class I
Cotton wool ball	Cotton wool ball	Class I
General-purpose medical fibre padding	General-purpose medical fibre padding	Class I
Non-woven gauze pad	Non-woven gauze pad	Class I
Wound dressing kit non-medicated	Wound dressing kit non-medicated	Class I
Wound dressing kit non-medicated	Wound dressing kit non-medicated	Class I
Wound dressing kit non-medicated	Wound dressing kit non-medicated	Class IIa