Registered with FDA
Andersen Caledonia Ltd
Bellshill, United Kingdom. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 4 markets
Where regulators' registries name Andersen Caledonia Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Andersen Caledonia Ltd | 3 device types | — | Below |
| Australia | TGA | Manufacturer | Andersen Caledonia Ltd | 1 | 2022–2022 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Andersen Caledonia Ltd | 1 | 2010–2010 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Andersen Caledonia Limited | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Andersen Caledonia Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | FORCEPS, DRESSING, DENTAL | 2025 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Lister | Syringe, cartridge | 2025 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | PUNCH, BIOPSY, SURGICAL | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ANDERSEN CALEDONIA LTDFDA reg. 3004530184 | Bellshill Scotland, United Kingdom | Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043114). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.