DH2
by Hangzhou Dalton BioSciences, Ltd. China EUDAMED
Ref DH2-096
EMDN W0105041003,W0105041005
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06973873140033 | Date15 Sep 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA) (trade name: DH2)
- Model / Reference
- DH2-096
- Primary DI / UDI-DI
- 06973873140033
- Basic UDI-DI
- B-06973873140033
- EMDN Code
- W0105041003,W0105041005
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000036196
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Hangzhou Dalton BioSciences, Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 06973873140033|B-06973873140033