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Automatic Nucleic Acid Detection and Analysis System
EUDAMEDClass A (EU MDR)
Ref AutoSAT Plus
Identity
- Device Name
- Automatic Nucleic Acid Detection and Analysis System EUDAMED
- Model / Reference
- AutoSAT Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974737220212 EUDAMED
- Basic UDI-DI
- 697473722AutoSAT47 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
Automatic Nucleic Acid Detection and Analysis System by Shanghai Rendu Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697473722AutoSAT47 | Class A | Active |
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Manufacturer
- Manufacturer
- Shanghai Rendu Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018869
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 22aa5a9d-dd8e-477a-b984-fe24b8842c80 61 fields · synced Jul 20, 2026