Identity
- Trade Name
- Specimen Preservation Solution EUDAMED
- Device Name
- Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA) EUDAMED
- Model / Reference
- SPS-045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973873141023 EUDAMED
- Basic UDI-DI
- 697387314DH3SQ EUDAMED
- Direct Marketing DI
- 06973873141023 EUDAMED
- EMDN Code
- W01040404 OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Specimen Preservation Solution by Hangzhou Dalton BioSciences, Ltd. — Class C — 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 | 697387314DH3SQ | Class C | Active |
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Manufacturer
- Manufacturer
- Hangzhou Dalton BioSciences, Ltd.
- EUDAMED SRN
- CN-MF-000036196
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 02f234a5-01f6-4099-a1d1-9a24c7d07cce 61 fields · synced Jul 15, 2026