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 - Relign Corporation

Address:

655 Campbell Technology Parkway Suite 275

Campbell

California 95008

United States

Authorised Representative/ UK Responsible Person
Name: Zimmer Biomet UK Limited
Address:

Stella Building Windmill Hill Business Park

Whitehill Way

Swindon

SN5 6NX

England United Kingdom

Code/Term Type

Arthroscopic shaver/electrosurgical system generator Arthroscopic shaver/electrosurgical system generator Class IIb

Arthroscopic shaver system blade single-use Arthroscopic shaver system blade single-use Class IIb

Orthopaedic bur single-use Orthopaedic bur single-use Class IIb

Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Class IIb

Arthroscopic shaver system handpiece electrically-powered Arthroscopic shaver system handpiece electrically-powered Class IIb

Endoscopic electrosurgical electrode bipolar single-use Endoscopic electrosurgical electrode bipolar single-use Class IIb

Surgical irrigation tubing set single-use Surgical irrigation tubing set single-use 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
Arthroscopic shaver/electrosurgical system generator	Arthroscopic shaver/electrosurgical system generator	Class IIb
Arthroscopic shaver system blade single-use	Arthroscopic shaver system blade single-use	Class IIb
Orthopaedic bur single-use	Orthopaedic bur single-use	Class IIb
Surgical irrigation/aspiration tubing set	Surgical irrigation/aspiration tubing set	Class IIb
Arthroscopic shaver system handpiece electrically-powered	Arthroscopic shaver system handpiece electrically-powered	Class IIb
Endoscopic electrosurgical electrode bipolar single-use	Endoscopic electrosurgical electrode bipolar single-use	Class IIb
Surgical irrigation tubing set single-use	Surgical irrigation tubing set single-use	Class IIb