humanITcare
Ref 4050750 / 5Model humanITcare
Withdrawn
CE MDD, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-ES-MF-0000139914K | Date4 Jan 2023 | StatusWithdrawn |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Withdrawn
Specification
- Model / Reference
- humanITcare, 4050750 / 5
- Primary DI / UDI-DI
- D-ES-MF-0000139914K
- Basic UDI-DI
- B-ES-MF-0000139914K
- EMDN Code
- Z12040192 General medicine diagnosis and monitoring instruments - medical device software
- Device Class
- Class I
- Special Device Type
- -1192
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000013991
Other devices from Followhealth S.L.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No