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 - Biomate Medical Devices Technology Co. Ltd.

Address:

1F No. 59 Luke 2nd Rd. Luzhu Dist.

Kaohsiung City

821

Taiwan

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

Enterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland

BT48 8SE

Northern Ireland United Kingdom

Code/Term Type

Dental implant system Dental implant system Class I

Dental implant suprastructure temporary preformed single-use Dental implant suprastructure temporary preformed single-use Class I

Fixture/appliance dental drill bit reusable Dental implant system Conformity Assessment Certificate Expired Class IIb

Fixture/appliance dental drill bit reusable Fixture/appliance dental drill bit reusable Conformity Assessment Certificate Expired Class IIa

Fixture/appliance dental drill bit reusable Dental implant suprastructure temporary preformed single-use Conformity Assessment Certificate Expired Class IIb

Fixture/appliance dental drill bit reusable Dental implant suprastructure temporary preformed single-use Conformity Assessment Certificate Expired 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
Dental implant system	Dental implant system	Class I
Dental implant suprastructure temporary preformed single-use	Dental implant suprastructure temporary preformed single-use	Class I
Fixture/appliance dental drill bit reusable	Dental implant system Conformity Assessment Certificate Expired	Class IIb
Fixture/appliance dental drill bit reusable	Fixture/appliance dental drill bit reusable Conformity Assessment Certificate Expired	Class IIa
Fixture/appliance dental drill bit reusable	Dental implant suprastructure temporary preformed single-use Conformity Assessment Certificate Expired	Class IIb
Fixture/appliance dental drill bit reusable	Dental implant suprastructure temporary preformed single-use Conformity Assessment Certificate Expired	Class IIa