Femur nail - UK MHRA Medical Device Registration

Femur nail is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 86524. The device is manufactured by Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.) from Malaysia, classified as General Medical Device. The authorized representative in the UK is Obelis UK 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

🇬🇧

Femur nail

MHRA Device ID: 86524•Ref: 86524

Device Type

General Medical Device

Devices

Femur nail

Type

Class IIa

Date Registered

Nov 26, 2024

Last Updated

Apr 27, 2024

Manufacturer Information

Name

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Address

308b, Jalan Perindustrian Bukit Minyak 18 Penang Science Park

Simpang Ampat, Penang, Malaysia

Created Date

Jun 26, 2021

Authorized Representative

Name

Obelis UK Ltd

Relationship Type

UK Responsible Person

Address

Sandford Gate, East Point Business Park

Oxford , England, United Kingdom

Postcode: OX4 6LB

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.) (10)

Other Products from Same Authorized Representative (10)

Femur nail - 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

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Nylon suture, non-bioabsorbable, monofilament

Nylon suture, non-bioabsorbable, multifilament

Orthopaedic bone nut

Orthopaedic bone screw, non-bioabsorbable, sterile

Orthopaedic bone washer, sterile

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Wound hydrogel dressing, non-antimicrobial

Bone nail end-cap

Humerus nail

Total cortisol IVD, reagent

Prothrombin time (PT) IVD, reagent

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

SARS-CoV-2 total/neutralizing antibody IVD, kit, rapid ICT, clinical

Activated partial thromboplastin time (APTT) IVD, control

Anti-Mullerian hormone (AMH) IVD, control

Ferritin IVD, kit, fluorescent immunoassay

Multiple autoimmune disease-associated antibody screening IVD, kit, fluorescent immunoassay

Glycated haemoglobin (HbA1c) IVD, kit, fluorescent immunoassay, rapid

Multiple stroke (cerebral vascular accident) marker IVD, kit, fluorescent immunoassay