Identity
- Trade Name
- HPV Sample Preservation Solution EUDAMED
- Device Name
- HPV Sample Preservation Solution EUDAMED
- Model / Reference
- PHPV01C-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739405 EUDAMED
- Basic UDI-DI
- 6973315739405AV EUDAMED
- EMDN Code
- W0104010204 SAMPLE TRANSPORT FOR NA TESTING EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
HPV Sample Preservation Solution by Nanjing Vazyme Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6973315739405AV | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3a107618-3e7d-4921-a528-f361c3a0672c 61 fields · synced Jun 18, 2026