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 - ClearPoint Neuro Inc.

Address:

5 Musick

Irvine

California 92618

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

Neurological stereotactic surgery system Neurological stereotactic surgery system Class IIa

Skull clamp Skull clamp Class I

Patient surgical drape single-use Patient surgical drape single-use Class I

Intracerebral cannula nonimplantable single-use Intracerebral cannula nonimplantable single-use Conformity Assessment Certificate Expired Class III

Intracerebral cannula nonimplantable single-use Intracerebral cannula nonimplantable single-use Conformity Assessment Certificate Expired Class III

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
Neurological stereotactic surgery system	Neurological stereotactic surgery system	Class IIa
Skull clamp	Skull clamp	Class I
Patient surgical drape single-use	Patient surgical drape single-use	Class I
Intracerebral cannula nonimplantable single-use	Intracerebral cannula nonimplantable single-use Conformity Assessment Certificate Expired	Class III
Intracerebral cannula nonimplantable single-use	Intracerebral cannula nonimplantable single-use Conformity Assessment Certificate Expired	Class III