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Rapid Automatic Washer-Disinfector
EUDAMEDClass IIa (EU MDR)
Ref Smart-TModel Rapid-A-520, Rapid-M-320 ,Victor6000,Smart-L,Smart-TRef Smart-LRef Rapid-A-520
Identity
- Trade Name
- Rapid Automatic Washer-Disinfector EUDAMED
- Device Name
- Rapid Automatic Washer-Disinfector EUDAMED
- Model / Reference
- Rapid-A-520, Rapid-M-320 ,Victor6000,Smart-L,Smart-T EUDAMEDSmart-T EUDAMEDSmart-L EUDAMEDRapid-A-520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614965467 EUDAMED06970614965450 EUDAMED06970614964934 EUDAMED
- Basic UDI-DI
- 697061496120003R2 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia 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
Category: Surgical utensil washer/disinfector
Rapid Automatic Washer-Disinfector by Shinva Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697061496120003R2 | 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 (3)
- EUDAMED e4caad8b-17a9-4c7b-b95e-c876f15b59c8 61 fields · synced Jul 12, 2026
- EUDAMED 912ecb5b-7aee-4f1d-b116-a55283a79ea4 61 fields · synced May 18, 2026
- EUDAMED 3e71a95e-8958-4956-92e1-8f67718e2d21 61 fields · synced May 18, 2026