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HPV Genotyping MCA Real-time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref HBRT-40-048Model 40-HPV Genotype(A+B) ：48 Tests
Identity
- Device Name
- HPV Genotyping MCA Real-time PCR Kit EUDAMED
- Model / Reference
- 40-HPV Genotype(A+B) ：48 Tests EUDAMEDHBRT-40-048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942221705149 EUDAMED
- Basic UDI-DI
- B-06942221705149 EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
HPV Genotyping MCA Real-time PCR Kit by Chaozhou Hybribio Biochemistry 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-06942221705149 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chaozhou Hybribio Biochemistry Ltd.
- EUDAMED SRN
- CN-MF-000023818
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 773da49d-9795-4769-8517-c581a5f000cd 61 fields · synced Jul 9, 2026