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Isothermal Fluorescence PCR
EUDAMEDClass A (EU MDR)
Ref -Model Gene-8C;Gene-8C2
Identity
- Trade Name
- Isothermal Fluorescence PCR EUDAMED
- Device Name
- Isothermal Fluorescence PCR EUDAMED
- Model / Reference
- Gene-8C;Gene-8C2 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141981058 EUDAMED
- Basic UDI-DI
- 697514198AS161FB 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
Isothermal Fluorescence PCR 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 | 697514198AS161FB | 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 020aa960-843a-4a69-9123-61d1f96c96b4 61 fields · synced Jul 11, 2026