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High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit
EUDAMEDClass IVD General (EU MDR)
Ref TD-0324-04-48Ref TD-0324-02-48
Identity
- Trade Name
- High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit EUDAMEDHigh-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit（PCR-Fluorescence） EUDAMED
- Device Name
- High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit EUDAMEDHigh-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit（PCR-Fluorescence） EUDAMED
- Model / Reference
- TD-0324-04-48 EUDAMEDTD-0324-02-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042228582 EUDAMED06971042228568 EUDAMED
- Basic UDI-DI
- B-06971042228582 EUDAMEDB-06971042228568 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
High-risk Human Papillomavirus（HPV）Genotyping Real time PCR kit by Shanghai Zj Bio-Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06971042228582 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED bb8af0b8-fb6d-46cc-8393-7fcc103bbec1 61 fields · synced Oct 6, 2026
- EUDAMED 5ce07a0c-213e-44d7-9709-acbe74f6a9fc 61 fields · synced May 19, 2026