Single-chamber implantable defibrillator - UK MHRA Medical Device Registration

Single-chamber implantable defibrillator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 171628. The device is manufactured by BIOTRONIK SE & Co. KG from Germany, classified as General Medical Device. The authorized representative in the UK is BIOTRONIK UK LIMITED.

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

🇬🇧

Single-chamber implantable defibrillator

MHRA Device ID: 171628•Ref: 171628

Device Type

General Medical Device

Devices

Single-chamber implantable defibrillator

Type

Class III

Date Registered

Nov 26, 2024

Last Updated

Mar 6, 2024

Manufacturer Information

Name

BIOTRONIK SE & Co. KG

Address

Woermannkehre 1

Berlin, Germany

Created Date

Mar 8, 2021

Authorized Representative

Name

BIOTRONIK UK LIMITED

Relationship Type

UK Responsible Person

Address

BIOTRONIK House, Avonbury Business Park

Bicester, United Kingdom

Postcode: OX26 2UA

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from BIOTRONIK SE & Co. KG (10)

Other Products from Same Authorized Representative (10)

Single-chamber implantable defibrillator - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Bedside information system application software

Orthopaedic implant aiming/guiding block, reusable

Arthroplasty force sensor

Cervicothoracolumbosacral spine orthosis, rigid

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

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Radiology PACS software

Scanning-laser ophthalmic imaging system

Dental implant abutment trial

Physiologic monitoring system alarm

Electrical-only medical device connection cable, reusable

Electrocardiographic lead set, reusable

Electrical-only medical device connection cable, reusable

Cardiac pulse generator test magnet

Electrical-only medical device connection cable, single-use

Dual-chamber implantable defibrillator

Coronary venous pacing lead

Cardiac pulse generator reader, home-use

Electrocardiographic lead set, reusable

Cardiac resynchronization therapy implantable pacemaker

Coronary angioplasty balloon catheter, basic

Drug-eluting coronary artery stent, bioabsorbable-polymer-coated

Vascular guide-catheter, single-use

Cardiac/peripheral vascular guidewire, single-use

Peripheral angioplasty balloon catheter, basic

Peripheral angioplasty balloon catheter, basic

Peripheral artery stent, bare-metal

Cardiac electrophysiology stimulation system

Cardiac pulse generator programmer

Cardiac pulse generator programmer