newbox medical GmbH
DE-MF-000020279 · Germany · Münster
newbox medical GmbH is registered in the European database on medical devices as a manufacturer, with 1 546 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 225 |
|---|---|
| Class IIb | 321 |
Most frequent device types declared: ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE-OTHER, ARTHROSCOPY BLADES, SINGLE-USE, K-Wires non-sterile, K-Wires sterile, DR38-01.B.
Among these devices, 313 are declared sterile, 321 implantable, 554 reusable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NEWBOX MEDICAL GMBH (DE) · FDA 3021754493 |
| Devices in EUDAMED | 1 546 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0019 | amended | 2029-10-15 |