Pulse oximeter - UK MHRA Medical Device Registration

Pulse oximeter is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 94025. The device is manufactured by Newtech, Inc. from China, 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.

Free Database

MHRA Registered

General Medical Device

🇬🇧

Pulse oximeter

MHRA Device ID: 94025•Ref: 94025

Device Type

General Medical Device

Devices

Pulse oximeter

Type

Class IIb

Date Registered

Aug 12, 2021

Last Updated

Dec 22, 2022

Manufacturer Information

Name

Newtech, Inc.

Address

4/F Zhongjian Industrial Building One #402 18 Yanshan Road Shekou Nanshan District

Shenzhen, Guangdong , China

Created Date

Aug 12, 2021

Authorized Representative

Name

Advena Ltd

Relationship Type

UK Responsible Person

Address

Pure Offices Plato Close

Warwick, England, United Kingdom

Postcode: CV34 6WE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Newtech, Inc. (1)

Carbon dioxide monitor

Type: General Medical Device

Registered: Aug 12, 2021

Other Products from Same Authorized Representative (10)

Pulse oximeter - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Manual blood lancing device, single-use

Stationary gamma camera system

Physiologic monitoring system alarm

Bedside information system application software

Wireless patient monitor/sensor reporting software, professional-only

Wireless patient monitor/sensor reporting software, professional-only

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Orthopaedic implant aiming/guiding block, reusable

Bone nail guidewire, reusable

Carbon dioxide monitor

Myoelectric gastrointestinal motility analysis system

Dried blood spot collection kit IVD

General specimen container IVD, no additive/medium

Test tube/reservoir cap IVD

Myoelectric gastrointestinal motility analysis system

Assisted reproduction microtool

Chemiluminescent immunoassay analyser IVD

Assay container IVD, single-use

Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD

Dried blood spot collection receptacle IVD