Rhein 83 S.r.l.
IT-MF-000005998 · Italy · Bologna
Rhein 83 S.r.l. is registered in the European database on medical devices as a manufacturer, with 738 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 736 |
|---|---|
| Class IIb | 2 |
Among these devices, 2 are declared implantable, 19 reusable.
Devices declared under this manufacturer
- ANELLO DIREZIONALE 14° rosso pz.10
- CAPP.SMART BOX NERA da lab. 10u.
- CASTABLE POSITIONER MICRO s. 50 PZ.
- CHIAVE QUADRATA OT EQUATOR h10.5
- CHIAVE x PARALLELOMETRO Multis. x Barra
- Cappette Equator Nere da labor. pz.4
- ESTR/CAPP. c/st. INSERITORE STRATEGY UDI
- ESTRATTORE CAPP. c/st. INSERIT. EQUATOR
- OT EQUATOR ANALOG FOR LAB
- PATRICI CALC. LUNGHE STRATEGY pz.4
- PERNI CALC. NORMO ROSSI mm. 9 pz.20
- PERNO CALC. MICRO mm.10 100u.
Showing 12 of 738 declared devices.
Catalogue references include 010PSP17, 054PLS, 083ICP, 190IS, 902654, AD14-10.
European nomenclature codes declared: Q010199, Q010207, Q010280, Q010299, Q010499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 738 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 738 |
|---|---|
| Found in the U.S. device database | 180 |
| Share | 24.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | RHEIN 83 S.R.L. |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 1 |
| First licensed | 2011-02-04 |
Licence types: Device Family (3).
Licensed under: PLASTIC DENTAL ATTACHMENTS, STAINLESS STEEL DENTAL ATTACHMENTS, ABUTMENT FOR OVERDENTURE.
North American profile: Canada only. Rhein 83 S.r.l. holds a Canadian licence but was not found in the U.S. register.