Hybrid Night Splint, Small - Medium
Ref 30014Model Hybrid Night Splint
Hybrid Night Splint, Small - Medium (30014) is a Class I device made by Ovation Medical, registered in EUDAMED on 13 Apr 2026 (Basic UDI-DI 081004743CZT), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081004743CZT 00810047430438 | Date13 Apr 2026 | StatusActive |
Official records
- EUDAMED public site 081004743CZT
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- Withdrawn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/MDR Active
Specification
- Device name
- Night Splint Devices
- Model / reference
- Hybrid Night Splint, 30014
- Primary DI / UDI-DI
- 00810047430438
- Basic UDI-DI
- 081004743CZT
- EMDN code
- Y06120601 Passive ankle-foot orthoses
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000051616
- Authorised representative
- MDSS GmbH DE-AR-000005430
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