Orthopaedic bone nut - UK MHRA Medical Device Registration

Orthopaedic bone nut is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 86523. 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.

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Orthopaedic bone nut

MHRA Device ID: 86523•Ref: 86523

Device Type

General Medical Device

Devices

Orthopaedic bone nut

Type

Class IIb

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

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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)

Orthopaedic bone nut - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Bone awl, reusable

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Bedside physiologic monitoring software

Orthopaedic knee/leg holder liner

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

Nylon suture, non-bioabsorbable, monofilament

Nylon suture, non-bioabsorbable, multifilament

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

Femur nail

Humerus nail

Total cortisol IVD, reagent

Prothrombin time (PT) IVD, reagent

Isolation gown, single-use

Absorbent underpad, non-antimicrobial, single-use

Eye pad

Surgical instrument assist arm system, manually-adjusted

Moisture/lubrication otic solution

Hand-held telescope

Cotton wool ball, sterile

Non-woven gauze pad