Otoscope, direct - UK MHRA Medical Device Registration

Otoscope, direct is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 195285. The device is manufactured by hearX SA (Pty) Ltd from South Africa, classified as General Medical Device. The authorized representative in the UK is Advena 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.

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Otoscope, direct

MHRA Device ID: 195285•Ref: 195285

Device Type

General Medical Device

Devices

Otoscope, direct

Type

Class I

Date Registered

Nov 26, 2024

Last Updated

Feb 16, 2024

Manufacturer Information

Name

hearX SA (Pty) Ltd

Address

Ground Floor, Building 2 Ashlea Gardens Office Park 180 Garsfontein Road Ashlea Gardens

Pretoria, South Africa

Created Date

Feb 14, 2024

Authorized Representative

Name

Advena Ltd

Relationship Type

UK Responsible Person

Address

Pure Offices Plato Close

Warwick, England, United Kingdom

Postcode: CV34 6WE

DJ Fang

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Other Products from hearX SA (Pty) Ltd (1)

Tone audiometer

Type: General Medical Device

Registered: Nov 26, 2024

Other Products from Same Authorized Representative (10)

Otoscope, direct - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Arm procedure positioner, reusable

Headband, reusable

Bone fixation plate pliers insert

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Orthopaedic knee/leg holder liner

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