Automatic Nucleic Acid Detection and Analysis System
EUDAMEDClass A (EU MDR)
Identity
- Device Name
- Automatic Nucleic Acid Detection and Analysis System EUDAMED
- Model / Reference
- AutoSAT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974737220205 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
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Category: Nucleic acid sample preparation instrument IVD
The Automatic Nucleic Acid Detection and Analysis System (ANADS) is a cutting-edge medical device designed for accurate and reliable detection of nucleic acids in various biological samples. By leveraging advanced technologies such as PCR, DNA sequencing, and fluorescence detection, ANADS provides a comprehensive diagnostic solution for clinicians to make informed decisions about patient care.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
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 cea3167f-8b1b-4926-a86e-daed9c72ba0e 61 fields · synced Jul 15, 2026