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 - Hartwell Medical LLC

Address:

6354 Corte del Abeto Suite F

Carlsbad

California 92011

United States

Authorised Representative/ UK Responsible Person
Name: BTME Group Ltd
Address:

Unit 3 Stag Business Park Deer Park Way

Donnington Wood

Telford

Shropshire TF2 7NA

England United Kingdom

Code/Term Type

Vacuum mouldable splint Vacuum mouldable splint Class I

Patient positioning vacuum mattress Patient positioning vacuum mattress Class I

Head/neck immobilizer reusable Head/neck immobilizer reusable Class I

Spine board Spine board Class I

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
Vacuum mouldable splint	Vacuum mouldable splint	Class I
Patient positioning vacuum mattress	Patient positioning vacuum mattress	Class I
Head/neck immobilizer reusable	Head/neck immobilizer reusable	Class I
Spine board	Spine board	Class I