NeoBeat Newborn Heart Rate Meter
Ref 532-00033Model NeoBeat (IE) (LM), Newborn Heart Rate Meter
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-07045432081527 07045432081527 | Date27 Oct 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- NeoBeat
- Model / Reference
- NeoBeat (IE) (LM), Newborn Heart Rate Meter, 532-00033
- Primary DI / UDI-DI
- 07045432081527
- Basic UDI-DI
- B-07045432081527
- EMDN Code
- Z12080103 Foetal heartbeat detectors
- Device Class
- Class IIa
- EU market of registration
- Norway
Manufacturer details
- EUDAMED SRN
- NO-MF-000000012
Other devices from Laerdal Medical AS
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