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, D3106-S, D5-310-S, D519-40-250-S.
Among these devices, 313 are declared sterile, 321 implantable, 554 reusable.
Devices declared under this manufacturer
- SB30-403.1
- SB30-501.1
- SB31-301
- SB40-230
- SB41-401
- SB52-409S
- SB52-502S.1
- SB60-402
- SB60-503.1
- SB62-240
- SB64-560
- SB65-403.1
Showing 12 of 1 546 declared devices.
Catalogue references include DR38-01.B, KW02-150-12.A-S, KWT02-150-12.A, SB30-403.1, SB30-501.1, SB60-402.
European nomenclature codes declared: L1999, K030203, P09120301, P091302, Z12130503.
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 |
Device-level evidence
| Devices with a numeric GTIN | 1 546 |
|---|---|
| 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: United States only. newbox medical GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0019 | amended | 2029-10-15 |