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 - PENTAX of the Americas Inc.

Address:

3 Paragon Drive

Montvale

NJ 07645-1782

United States

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

Unit D1 Heron Drive

Langley

Slough

Berks sl3 8pn

England United Kingdom

Code/Term Type

Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Class IIa

General cryosurgical system cryogen gas electronic General cryosurgical system cryogen gas electronic Class IIa

Nitrous oxide gas cartridge Nitrous oxide gas cartridge Class IIa

Laryngostroboscope Laryngostroboscope Class I

Medical image management system Medical image management system 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
Gastrointestinal/biliary dilation balloon catheter	Gastrointestinal/biliary dilation balloon catheter	Class IIa
General cryosurgical system cryogen gas electronic	General cryosurgical system cryogen gas electronic	Class IIa
Nitrous oxide gas cartridge	Nitrous oxide gas cartridge	Class IIa
Laryngostroboscope	Laryngostroboscope	Class I
Medical image management system	Medical image management system	Class I