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 - X-Nav Technologies LLC

Address:

1555 Bustard Road Suite 75

PA

Lansdale 19446

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

Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Class IIa

Craniofacial bone screw non-bioabsorbable non-sterile Craniofacial bone screw non-bioabsorbable non-sterile Class IIa

Dental appliance fabrication material thermoplastic Dental appliance fabrication material thermoplastic 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
Surgical planning/navigation-enhancement system	Surgical planning/navigation-enhancement system	Class IIa
Craniofacial bone screw non-bioabsorbable non-sterile	Craniofacial bone screw non-bioabsorbable non-sterile	Class IIa
Dental appliance fabrication material thermoplastic	Dental appliance fabrication material thermoplastic	Class I