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Genedian
EUDAMEDClass IVD General (EU MDR)
Ref P122-08048; P122-08240; P122-08480
Identity
- Trade Name
- GENEDIAN EUDAMED
- Device Name
- Human Papillomavirus DNA Test Kit(Fluorescence Melting Curve Method) EUDAMED
- Model / Reference
- P122-08048; P122-08240; P122-08480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RA005UK EUDAMED
- Basic UDI-DI
- B-RA005UK EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Genedian by Hangzhou DIAN Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-RA005UK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou DIAN Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007252
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 5dac7ed1-0b72-4656-b8d1-93feed0c3fa3 61 fields · synced Jun 19, 2026
- EUDAMED 5dac7ed1-0b72-4656-b8d1-93feed0c3fa3-1 61 fields · synced Jun 10, 2026