RGB MEDICAL DEVICES, S.A.
ES-MF-000023793 · Spain · MADRID
RGB MEDICAL DEVICES, S.A. is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 13 |
|---|---|
| Class IIb | 3 |
Among these devices, 3 are declared active, 3 with a measuring function.
Devices declared under this manufacturer
- Disposable NMT/BP Cuff Adult size
- Disposable NMT/BP Cuff Large Adult size
- Disposable NMT/BP Cuff Small Adult size
- NMT/BP Cuff Adult size
- NMT/BP Cuff Extra-Large Adult size
- NMT/BP Cuff Large Adult size
- NMT/BP Cuff Small Adult size
- NMT/BP Extension Cable
- NMT/BP Pediatric size
- Vision AIR
- Vision DUO
Showing 12 of 16 declared devices.
Catalogue references include 1800-3C, 6220, 6255, 6710, 6730, 6745.
European nomenclature codes declared: Z1203020285, Z1203020201, Z1203020202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| 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. RGB MEDICAL DEVICES, S.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023 CR 0003 | issued | 2028-07-25 |