Identity
- Model / Reference
- D58-40-000-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04059216166365 EUDAMED
- Basic UDI-DI
- B-04059216166365 EUDAMED
- EMDN Code
- P091302 ORTHOPAEDIC IMPLANT BLADES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
D58-40-000-S by newbox medical GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04059216166365 | Class IIa | Active |
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Manufacturer
- Manufacturer
- newbox medical GmbH
- EUDAMED SRN
- DE-MF-000020279
Sources (1)
- EUDAMED 7ce30401-e529-4831-96dc-7e419077d2e4 61 fields · synced Jun 19, 2026