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 - Jiangsu Changmei Medtech Co. Ltd.

Address:

No.27 Xinke West Road Luoyang

Changzhou Jiangsu

213104

China

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

16 Castle St.

Dover

Kent CT16 1PW

England United Kingdom

Code/Term Type

Catheter/overtube balloon inflator single-use Catheter/overtube balloon inflator single-use Class I

Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator Class IIa

Gastro-urological guidewire single-use Gastro-urological guidewire single-use Class IIa

Kyphoplasty balloon catheter Kyphoplasty balloon catheter Class IIa

Bone access channel kit Bone access channel kit 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
Catheter/overtube balloon inflator single-use	Catheter/overtube balloon inflator single-use	Class I
Endoscopic gastrointestinal stenosis dilator	Endoscopic gastrointestinal stenosis dilator	Class IIa
Gastro-urological guidewire single-use	Gastro-urological guidewire single-use	Class IIa
Kyphoplasty balloon catheter	Kyphoplasty balloon catheter	Class IIa
Bone access channel kit	Bone access channel kit	Class IIa