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Sb64-404
EUDAMEDClass IIa (EU MDR)
Ref SB64-404Model ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE-OTHERRef SB64-404.1
Identity
- Trade Name
- SB64-404 EUDAMEDSB64-404.1 EUDAMED
- Model / Reference
- ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE-OTHER EUDAMEDSB64-404 EUDAMEDSB64-404.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04059216080418 EUDAMED04059216164675 EUDAMED
- Basic UDI-DI
- B-04059216080418 EUDAMEDB-04059216164675 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
Sb64-404 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-04059216080418 | Class IIa | Active |
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Manufacturer
- Manufacturer
- newbox medical GmbH
- EUDAMED SRN
- DE-MF-000020279
Sources (2)
- EUDAMED f6ef8432-69b1-4aa2-80ec-c0b2577e3c04 61 fields · synced Oct 6, 2026
- EUDAMED ac99844f-8d46-48c8-a798-cbd762f5641f 61 fields · synced May 18, 2026