← Back to catalogue
Sb64-540
EUDAMEDClass IIa (EU MDR)
Ref SB64-540Model ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE-OTHERRef SB64-540.1
Identity
- Trade Name
- SB64-540 EUDAMEDSB64-540.1 EUDAMED
- Model / Reference
- ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE-OTHER EUDAMEDSB64-540 EUDAMEDSB64-540.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04059216082801 EUDAMED04059216166938 EUDAMED04059216082672 EUDAMED
- Basic UDI-DI
- B-04059216082801 EUDAMEDB-04059216166938 EUDAMEDB-04059216082672 EUDAMED
- EMDN Code
- L1999 ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Sb64-540 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-04059216082801 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- newbox medical GmbH
- EUDAMED SRN
- DE-MF-000020279
Sources (3)
- EUDAMED a6940994-575d-4a5c-8da3-67dac589b772 61 fields · synced Oct 6, 2026
- EUDAMED 8108fe16-2662-4471-a774-48b9e683d10b 61 fields · synced May 19, 2026
- EUDAMED 10e95003-3208-4196-9dc3-097071302e43 61 fields · synced May 19, 2026