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 - Haemonetics S.A.

Address:

Haemonetics S.A.

Rue de flecheres Signy Centre

Signy

Vaud 1274

Switzerland

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

Lynwood House 373-375 Station Road

Harrow

Middlesex

HA1 2AW

England United Kingdom

Code/Term Type

Apheresis system tubing set Apheresis system tubing set Class IIa

Blood cell freeze/thaw system set Blood cell freeze/thaw system set Class IIb

Platelet aggregation study IVD reagent Platelet aggregation study IVD reagent Class IIb

Multiple coagulation factor IVD reagent Multiple coagulation factor IVD reagent IVD General

Multiple coagulation factor IVD control Multiple coagulation factor IVD control IVD General

Coagulation analyser IVD laboratory Coagulation analyser IVD laboratory IVD General

Coagulation analyser IVD laboratory Coagulation analyser IVD laboratory IVD General

Coagulation analyser IVD laboratory Coagulation analyser IVD laboratory Class A

Coagulation analyser IVD laboratory Coagulation analyser IVD laboratory Class A

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
Apheresis system tubing set	Apheresis system tubing set	Class IIa
Blood cell freeze/thaw system set	Blood cell freeze/thaw system set	Class IIb
Platelet aggregation study IVD reagent	Platelet aggregation study IVD reagent	Class IIb
Multiple coagulation factor IVD reagent	Multiple coagulation factor IVD reagent	IVD General
Multiple coagulation factor IVD control	Multiple coagulation factor IVD control	IVD General
Coagulation analyser IVD laboratory	Coagulation analyser IVD laboratory	IVD General
Coagulation analyser IVD laboratory	Coagulation analyser IVD laboratory	IVD General
Coagulation analyser IVD laboratory	Coagulation analyser IVD laboratory	Class A
Coagulation analyser IVD laboratory	Coagulation analyser IVD laboratory	Class A