Ortho-Care (UK) Limited
GB-MF-000010884 · United Kingdom · Saltaire
Ortho-Care (UK) Limited is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 108 |
|---|
Most frequent device types declared: 9001-ART02, Aligner Chews, Excel Aligner and Retainer Material, Ortho-Care Relief Wax, Orthodontic Alginate.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- 6” STAINLESS STEEL RULER DOUBLE SIDE 9MM/INCHES)
- BONDING TWEEZER 13.5CM
- BONDING TWEEZER 14CM
- DISTAL BENDER DOUBLE ENDED
- Dura-Chain Narrow Link (Blue label)
- Fresh & Go Aligner & Retainer Cleaning Tablets - 4 tablet pack
- HOLLOW CHOP PLIERS HEAVY
- MP2 10kg Acrylic polymer powder
- ORTHO-CARE MOLAR BOND TWEEZERS
- ORTHOCARE BRACKET REMOVERS
- ORTHOCARE CINCH BACK PLIERS
- ORTHOCARE DISTAL END CUTTER MINI LONG HANDLE WITH FLUSH END
Showing 12 of 108 declared devices.
Catalogue references include 3002-849, 4150-921, 4150-921E, 60-816, 63-10106, 63-10106LM.
European nomenclature codes declared: L150702, L150799, Q010499, L150703, Q010503, Q01010105.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 108 |
| 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 | 108 |
|---|---|
| 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. Ortho-Care (UK) Limited was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 815649 | issued | 2031-06-25 |