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HarmoniaHPV Test
EUDAMEDClass IVD General (EU MDR)
Ref TD-0552-02-25Ref TD-0552-02-100
Identity
- Trade Name
- HarmoniaHPV Test EUDAMED
- Device Name
- HarmoniaHPV Test EUDAMED
- Model / Reference
- TD-0552-02-25 EUDAMEDTD-0552-02-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042225239 EUDAMED06971042225253 EUDAMED
- Basic UDI-DI
- B-06971042225239 EUDAMEDB-06971042225253 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
HarmoniaHPV Test by Shanghai Zj Bio-Tech 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-06971042225239 | 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 e3f3a8c2-59f5-418e-b34c-d94a6dcc78d9 61 fields · synced Jul 28, 2026
- EUDAMED 1aa47508-b85f-4021-82d8-a15ccd60c496 61 fields · synced May 17, 2026