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Automated PCR Setup System
EUDAMEDClass A (EU MDR)
Ref -Model Au-Mate 96 A2、Au-Mate 96 A4、Au-Mate 96 B2、Au-Mate 96 B4、Auto-NRT 100
Identity
- Trade Name
- Automated PCR Setup System EUDAMED
- Device Name
- Liquid Handling Workstation EUDAMED
- Model / Reference
- Au-Mate 96 A2、Au-Mate 96 A4、Au-Mate 96 B2、Au-Mate 96 B4、Auto-NRT 100 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141981119 EUDAMED
- Basic UDI-DI
- 697514198AS228FJ EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated PCR Setup System by Hangzhou Allsheng Instruments Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697514198AS228FJ | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Allsheng Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000020502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 1361a6c9-e4a5-4bd6-9be2-8aa08e85f613 61 fields · synced Jun 19, 2026