← Back to catalogue
High Risk Human Papillomavirus (HPV) Genotyping System
EUDAMEDClass IVD General (EU MDR)
Ref HPVS02
Identity
- Trade Name
- High Risk Human Papillomavirus (HPV) Genotyping System EUDAMED
- Device Name
- High Risk Human Papillomavirus (HPV) Genotyping System EUDAMED
- Model / Reference
- HPVS02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973873149074 EUDAMED
- Basic UDI-DI
- B-06973873149074 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Portugal 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 System by Hangzhou Dalton BioSciences, 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-06973873149074 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Dalton BioSciences, Ltd.
- EUDAMED SRN
- CN-MF-000036196
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 4d948f06-234e-4ab1-83e0-8fdea9774bec 61 fields · synced Jun 18, 2026