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 - BMC Medical Co. Ltd.

Address:

Room 110 Tower A Fengyu Building No.115 Fucheng Road

Haidian

Beijing

100036

China

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

16 Castle St.

Dover

Kent CT16 1PW

England United Kingdom

Code/Term Type

Polysomnograph Polysomnograph Class IIa

CPAP/BPAP face mask single-use CPAP/BPAP face mask single-use Class IIa

CPAP/BPAP face mask reusable CPAP/BPAP face mask reusable Class IIa

CPAP/BPAP nasal mask reusable CPAP/BPAP nasal mask reusable Class IIa

Home CPAP unit Home CPAP unit Class IIa

Home BPAP unit Home BPAP unit Class IIa

Professional high-flow respiratory unit Professional high-flow respiratory unit Class IIa

Ventilator breathing circuit reusable Ventilator breathing circuit reusable Class IIa

Ventilator breathing circuit single-use Ventilator breathing circuit single-use 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
Polysomnograph	Polysomnograph	Class IIa
CPAP/BPAP face mask single-use	CPAP/BPAP face mask single-use	Class IIa
CPAP/BPAP face mask reusable	CPAP/BPAP face mask reusable	Class IIa
CPAP/BPAP nasal mask reusable	CPAP/BPAP nasal mask reusable	Class IIa
Home CPAP unit	Home CPAP unit	Class IIa
Home BPAP unit	Home BPAP unit	Class IIa
Professional high-flow respiratory unit	Professional high-flow respiratory unit	Class IIa
Ventilator breathing circuit reusable	Ventilator breathing circuit reusable	Class IIa
Ventilator breathing circuit single-use	Ventilator breathing circuit single-use	Class IIa