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 - Biosculptor Corporation

Address:

Trading as: Maramed Orthopedic Systems 2480 West 82nd Street

Hialeah

Florida 33016

United States

Authorised Representative/ UK Responsible Person
Name: Eurolink (Europe) Limited
Address:

Milestone House Longcot Road

Shrivenham

Swindon

Wilts SN6 8AL

United Kingdom

Code/Term Type

Cranial orthosis Cranial orthosis Class IIa

Hand orthosis Hand orthosis Class I

Wrist/hand/finger extension orthosis Wrist/hand/finger extension orthosis Class I

Wrist immobilizer single-use Wrist immobilizer single-use Class I

Arm splint system thermoplastic Arm splint system thermoplastic Class I

Leg splint system thermoplastic Leg splint system thermoplastic Class I

Ankle/foot orthosis Ankle/foot orthosis Class I

Upper-limb traction wrap/trap single-use Upper-limb traction wrap/trap single-use Class I

Stockinette Stockinette 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
Cranial orthosis	Cranial orthosis	Class IIa
Hand orthosis	Hand orthosis	Class I
Wrist/hand/finger extension orthosis	Wrist/hand/finger extension orthosis	Class I
Wrist immobilizer single-use	Wrist immobilizer single-use	Class I
Arm splint system thermoplastic	Arm splint system thermoplastic	Class I
Leg splint system thermoplastic	Leg splint system thermoplastic	Class I
Ankle/foot orthosis	Ankle/foot orthosis	Class I
Upper-limb traction wrap/trap single-use	Upper-limb traction wrap/trap single-use	Class I
Stockinette	Stockinette	Class I