Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft - UK MHRA Medical Device Registration

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 168041. The device is manufactured by On-X Life Technologies, Inc. from United States, classified as General Medical Device. The authorized representative in the UK is OMC MEDICAL Ltd.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

MHRA Registered

General Medical Device

🇬🇧

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

MHRA Device ID: 168041•Ref: 168041

Device Type

General Medical Device

Devices

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

Type

Class III

Date Registered

Nov 26, 2024

Last Updated

Apr 16, 2024

Manufacturer Information

Name

On-X Life Technologies, Inc.

Address

1300 E Anderson Ln

Austin, Texas, United States

Created Date

Mar 8, 2023

Authorized Representative

Name

OMC MEDICAL Ltd

Relationship Type

UK Responsible Person

Address

Planet House North Heath Lane

Horsham, West Sussex, United Kingdom

Postcode: RH12 5QE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from On-X Life Technologies, Inc. (4)

Other Products from Same Authorized Representative (10)

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Bone-resection orthopaedic reamer, reusable

Eye lubricant

Tocodynamometer probe

Adhesive bandage

Orthopaedic casting stand

Eye irrigation solution, synthetic

Electric-motor-driven wheelchair, occupant-controlled

Urodynamic manometric catheter, non-electronic

Laparoscopic motorized instrument control unit

Custom-made talus prosthesis

Heart valve annulus sizer, reusable

Mitral bi-leaflet mechanical heart valve prosthesis

Aortic bi-leaflet mechanical heart valve prosthesis

Heart valve repair/prosthesis implantation kit

Electric-motor-driven wheelchair, occupant-controlled

Elbow crutch

Laser filter, optical

General/multiple surgical frequency-doubled solid-state laser system

Indirect binocular laser ophthalmoscope

Laser adaptor

Ophthalmic solid-state laser system

Urogenital surgical laser system beam guide, single-use

Clinical management support software

Handgrip disability-assistive walker, non-powered, non-foldable