Atk Hpv
by Arghavan Teb Kavian Iran EUDAMED
Ref ATK.R011
EMDN W0105041002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number62600011ATK.HPV4D | Date25 Dec 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- HPV High Risk Real Time PCR Kit
- Model / Reference
- ATK.R011
- Primary DI / UDI-DI
- 06260001187795
- Basic UDI-DI
- 62600011ATK.HPV4D
- EMDN Code
- W0105041002 Screening high-risk hpv - na reagents
- Device Class
- Class C
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- IR-MF-000045430
- Authorised representative
- Medisol Technologies S.L. ES-AR-000044726
Other devices from Arghavan Teb Kavian
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED e4fd54de-eccb-4eb4-b165-f4814b57a3b2