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Sb55-401s
EUDAMEDClass IIa (EU MDR)
Ref SB55-401SModel ARTHROSCOPY BLADES, SINGLE-USERef SB55-401S.1
Identity
- Trade Name
- SB55-401S EUDAMEDSB55-401S.1 EUDAMED
- Model / Reference
- ARTHROSCOPY BLADES, SINGLE-USE EUDAMEDSB55-401S EUDAMEDSB55-401S.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04059216081354 EUDAMED04059216165610 EUDAMED
- Basic UDI-DI
- B-04059216081354 EUDAMEDB-04059216165610 EUDAMED
- EMDN Code
- K030203 ARTHROSCOPY BLADES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Sb55-401s 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-04059216081354 | Class IIa | Active |
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Manufacturer
- Manufacturer
- newbox medical GmbH
- EUDAMED SRN
- DE-MF-000020279
Sources (2)
- EUDAMED 6d18b3fd-3fa4-46ce-a027-b2a0df1aa291 61 fields · synced Oct 6, 2026
- EUDAMED dca74677-7026-4a9b-8e40-e3c31e000bd1 61 fields · synced May 16, 2026