Hand-held intraoral dental x-ray system, digital - UK MHRA Medical Device Registration

Hand-held intraoral dental x-ray system, digital is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 93165. The device is manufactured by Osstem Implant Co., Ltd from South Korea, 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

🇬🇧

Hand-held intraoral dental x-ray system, digital

MHRA Device ID: 93165•Ref: 93165

Device Type

General Medical Device

Devices

Hand-held intraoral dental x-ray system, digital

Type

Class IIb

Date Registered

Nov 26, 2024

Last Updated

Mar 14, 2024

Manufacturer Information

Name

Osstem Implant Co., Ltd

Address

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea A-dong, 51, Mayu-ro, 238beon-gil, Siheung-si, Gyeonggi-do, Korea

Busan; Siheung-si, South Korea

Created Date

May 11, 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 Osstem Implant Co., Ltd (10)

Other Products from Same Authorized Representative (10)

Hand-held intraoral dental x-ray system, digital - 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

Bone lever/elevator, reusable

Bone tap, reusable

Chisel/osteotome blade handle

Dental bone matrix implant, animal-derived

Dental bone matrix implant, synthetic

Dental delivery system

Dental elevator, sinus lift

Dental implant abutment trial

Dental implant holding endpiece

Bone lever/elevator, reusable

Total cortisol IVD, reagent

Prothrombin time (PT) IVD, reagent

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

Nucleic acid sequencing reagent kit IVD

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

Anti-Mullerian hormone (AMH) IVD, control

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

Ferritin IVD, kit, fluorescent immunoassay

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

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