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Human Papillomavirus（HPV）DNA Diagnostic Kit
EUDAMEDClass IVD General (EU MDR)
Ref 3000000000366Model 50 tests/kit
Identity
- Trade Name
- Human Papillomavirus（HPV）DNA Diagnostic Kit EUDAMED
- Device Name
- Human Papillomavirus（HPV）DNA Diagnostic Kit EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED3000000000366 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685471318 EUDAMED
- Basic UDI-DI
- B-06973685471318 EUDAMED
- EMDN Code
- W0105041002 SCREENING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Human Papillomavirus（HPV）DNA Diagnostic Kit by 3D Biomedicine Science & Technology Co., Limited — 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-06973685471318 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- 3D Biomedicine Science & Technology Co., Limited
- EUDAMED SRN
- CN-MF-000020934
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 148d2929-f93c-4b4d-8d7b-af27ae5a6ce5 61 fields · synced Jun 19, 2026