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 - Galt Medical Corp.

Address:

2220 Merritt Drive

Garland

Texas 75041

United States

Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge

CB24 9BZ

England United Kingdom

Code/Term Type

Haemostasis valve Haemostasis valve Class IIa

Vascular catheter introduction needle Vascular catheter introduction needle Class IIa

Closed-wound drain non-bioabsorbable Closed-wound drain non-bioabsorbable Class IIa

Peripheral vascular guidewire manual Peripheral vascular guidewire manual Class IIa

Vascular dilator single-use Vascular dilator single-use Class IIa

Cardiac/peripheral vascular guidewire single-use Cardiac/peripheral vascular guidewire single-use Class III

Vascular catheter introduction set nonimplantable Vascular catheter introduction set nonimplantable Class III

Vascular catheter introduction set nonimplantable Vascular catheter introduction set nonimplantable 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
Haemostasis valve	Haemostasis valve	Class IIa
Vascular catheter introduction needle	Vascular catheter introduction needle	Class IIa
Closed-wound drain non-bioabsorbable	Closed-wound drain non-bioabsorbable	Class IIa
Peripheral vascular guidewire manual	Peripheral vascular guidewire manual	Class IIa
Vascular dilator single-use	Vascular dilator single-use	Class IIa
Cardiac/peripheral vascular guidewire single-use	Cardiac/peripheral vascular guidewire single-use	Class III
Vascular catheter introduction set nonimplantable	Vascular catheter introduction set nonimplantable	Class III
Vascular catheter introduction set nonimplantable	Vascular catheter introduction set nonimplantable	Class IIa