CLOTTY Coagulómetro semi-automático
by Ral Tecnica Para El Laboratorio, S.A.
Ref RA000144Model CLOTTY
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number84354919CLOTTY01F3 08435491999960 | Date3 Feb 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Clotty
- Model / Reference
- CLOTTY, RA000144
- Primary DI / UDI-DI
- 08435491999960
- Basic UDI-DI
- 84354919CLOTTY01F3
- Direct Marketing DI
- 08435491999960
- EMDN Code
- W0202020101 Semi-automated coagulometers
- Device Class
- Class A
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000000306
Other devices from Ral Tecnica Para El Laboratorio, S.A.
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Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No