Babychecker
by Delft Imaging Systems B.V. EUDAMED
Withdrawn
Ref Babychecker
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42624007202057 | Date1 May 2023 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Withdrawn
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- Babychecker
- Primary DI / UDI-DI
- 42624007202159
- Basic UDI-DI
- 42624007202057
- EMDN Code
- Z11040299 Ultrasound probes – other
- Device Class
- Class IIa
- Medical Purpose
- BabyChecker is powered by Artificial Intelligence to support the detection of risky pregnancies by community health workers and increase timely referrals.
Manufacturer details
- EUDAMED SRN
- NL-PR-000033500
Other devices from Delft Imaging Systems B.V.
Properties
Other properties (1)
- Sterile: No