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Automated NGS Library Preparation Workstation
EUDAMEDClass A (EU MDR)
Ref -Model Auto-NGS 100R
Identity
- Trade Name
- Automated NGS Library Preparation Workstation EUDAMED
- Device Name
- Automated NGS Library Preparation Workstation EUDAMED
- Model / Reference
- Auto-NGS 100R EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141981188 EUDAMED
- Basic UDI-DI
- 697514198AS230F5 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Automated NGS Library Preparation Workstation 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 | 697514198AS230F5 | 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 784dc99e-bf3d-47b0-a3b7-2143ca70f52d 61 fields · synced Jul 17, 2026