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Flexible Endoscope Washer-disinfector
EUDAMEDClass IIa (EU MDR)
Ref Rider50BModel Rider60A,Rider60B,Rider50A,Rider50B,Rider40B,Rider30B
Identity
- Trade Name
- Flexible Endoscope Washer-disinfector EUDAMED
- Device Name
- Flexible Endoscope Washer-disinfector EUDAMED
- Model / Reference
- Rider60A,Rider60B,Rider50A,Rider50B,Rider40B,Rider30B EUDAMEDRider50B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614965351 EUDAMED
- Basic UDI-DI
- 697061496120006R8 EUDAMED
- EMDN Code
- Z12011313 ENDOSCOPE STERILISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Flexible Endoscope Washer-disinfector by Shinva Medical Instrument Co., Ltd. — 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 | 697061496120006R8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shinva Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009856
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 6e1f2c0e-74af-4da2-b56a-ec9b5bc8066c 61 fields · synced Jun 18, 2026