Identity
- Device Name
- qPCR mix EUDAMED
- Model / Reference
- MK-PM EUDAMEDM202507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978543820031 EUDAMED
- Basic UDI-DI
- 6978543820031F3 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
qPCR mix by Aixgen Technology (Heze) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6978543820031F3 | Class A | Active |
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Manufacturer
- Manufacturer
- Aixgen Technology (Heze) Co., Ltd.
- EUDAMED SRN
- CN-MF-000047605
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED a82d1fd1-0ca9-4cb1-9c11-11be71e54e18 61 fields · synced Jun 18, 2026