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15 High-risk HPV DNA Diagnostic Kit(type16, 18, 31, 33, 35, 39, 45, 51, 52, 53,…
EUDAMEDClass IVD General (EU MDR)
Ref 18-01-0009Model 48 Tests/kit
Identity
- Trade Name
- 15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing) EUDAMED
- Device Name
- 15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- 48 Tests/kit EUDAMED18-01-0009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674892497 EUDAMED
- Basic UDI-DI
- B-06974674892497 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
15 High-risk HPV DNA Diagnostic Kit(type16, 18, 31, 33, 35, 39, 45, 51, 52, 53,… by Shenzhen Zijian Biotechnology Co., Ltd — Class IVD General — IVDD — listed…
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-06974674892497 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a731b590-849c-4f7c-a6ad-bb075e4bc496 61 fields · synced Oct 6, 2026