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37 HPV GenoArray Diagnostic Kit
EUDAMEDClass IVD General (EU MDR)
Ref HBGA-37Model 90 Tests/Kit
Identity
- Device Name
- 37 HPV GenoArray Diagnostic Kit EUDAMED
- Model / Reference
- 90 Tests/Kit EUDAMEDHBGA-37 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942221703848 EUDAMED
- Basic UDI-DI
- B-06942221703848 EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-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
37 HPV GenoArray Diagnostic 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-06942221703848 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chaozhou Hybribio Biochemistry Ltd.
- EUDAMED SRN
- CN-MF-000023818
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c5cc90d7-15a7-41c4-ba2a-70bcd14b41d6 61 fields · synced Jul 9, 2026