Identity
- Trade Name
- Real-time PCR system EUDAMED
- Device Name
- Real-time PCR system EUDAMED
- Model / Reference
- Q8801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975412631078 EUDAMED
- Basic UDI-DI
- 697541263PCRSPB EUDAMED
- Direct Marketing DI
- 16975412631078 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
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Real-time PCR system by Hangzhou Bio-gener Technology 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 | 697541263PCRSPB | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bio-gener Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027988
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED d4777040-cec3-4cc2-81a1-a0d7c84f6a8c 61 fields · synced Jun 19, 2026