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AlphaScope
EUDAMEDClass IIa (EU MDR)
Ref SCO.4103.30Model LaparoscopesRef SCO.4103.00
Identity
- Trade Name
- AlphaScope EUDAMED
- Model / Reference
- Laparoscopes EUDAMEDSCO.4103.30 EUDAMEDSCO.4103.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250480103524 EUDAMED04250480103517 EUDAMED
- Basic UDI-DI
- 42504801LAPAROSCOPESEF EUDAMED
- Direct Marketing DI
- 04250480103524 EUDAMED04250480103517 EUDAMED
- EMDN Code
- Z12029009 LAPAROSCOPES 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
AlphaScope by SCHÖLLY FIBEROPTIC GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504801LAPAROSCOPESEF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (2)
- EUDAMED 2ea85dcc-2252-4c3a-b484-ff1525b51600 61 fields · synced Jul 21, 2026
- EUDAMED fb08e94e-2991-4e4c-85b0-5fb598a93cb5 61 fields · synced May 17, 2026