OsteoCare Implant System Limited
GB-MF-000016843 · United Kingdom · Colnbrook
OsteoCare Implant System Limited is registered in the European database on medical devices as a manufacturer, with 292 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 127 |
|---|---|
| Class IIa | 164 |
| Class I | 1 |
Most frequent device types declared: Abutment, Abutments, Burs, Drivers and Connectors, Guide Tubes.
Among these devices, 127 are declared sterile, 198 implantable, 51 reusable.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Advanced Implant
- Bur Handpiece Driver
- Classic 2 Advanced Implant
- Impression Transfer
- Maxi Z Plus Implant
- Midi Ball Implant
- Mini Ball Implant
- Mini Post Implant
- Over-Hex Driver
- STS Bur
- Screw-Retained Abutment
- Screw-Retained Ball Attachment
Showing 12 of 292 declared devices.
Catalogue references include CO-ITC-5L, IM-A375-016, IM-MBT280-130, IM-MBT380-130, IM-MNP235-130, IN-BPO-190.
European nomenclature codes declared: P01020101, P01020180, L159007, L15901199, L150101, Q010207.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 292 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 292 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. OsteoCare Implant System Limited was not found in either the U.S. or the Canadian register.