OrbusNeich Medical, B.V.
NL-MF-000010907 · Netherlands · Hoevelaken
OrbusNeich Medical, B.V. is registered in the European database on medical devices as a manufacturer, with 511 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 329 |
|---|---|
| Class IIa | 182 |
Most frequent device types declared: 2.1 x 150 cm Control, Ø 3.0 x 180mm, Ø 3.5 x 40 mm, Ø 4.0 x 10 mm, Ø 4.0 x 15 mm.
Among these devices, 510 are declared sterile, 38 implantable.
Devices declared under this manufacturer
- Combo Plus
- Jade PTA
- Sapphire 3
- Sapphire II NC
- Sapphire II PRO
- Sapphire NC
- Sapphire NC 24
- Sapphire NC24
- Scoreflex
- Scoreflex NC
- Scoreflex PTA
- Teleport
Showing 12 of 511 declared devices.
Catalogue references include 221-15-2000, 225-184-5, 232-124-5, 240-154-5, 250-153-2, 535-040-41.
European nomenclature codes declared: C010401020101, C010402020101, P0704020102, P070402010301, C0104020205.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 511 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 511 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | ORBUS NEICH MEDICAL HOLDING B.V. |
⚠️ A similar name exists; unverified — why.