Splints
by Anping County Changtai Medical Equipment Factory 9 variants
Part of a family of 9 devices: see the family page
Ref 4.5*9.5CMModel 15*92CM、11*100CM、11*92CM、11*91CM、11*90CM、11*72CM、11*71CM、11*62CM、11*61CM、11*46CM、11*45CM、11*23CM、11*25CM、4.5*9.5CM or customized
Splints (4.5*9.5CM) is a Class I device made by Anping County Changtai Medical Equipment Factory, registered in EUDAMED on 2 Jun 2025 (Basic UDI-DI 697872927SplintsRY), active as of 22 Oct 2026.
Active
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 | Number697872927SplintsRY 06978729270339 | Date2 Jun 2025 | StatusActive |
Official records
- EUDAMED public site 697872927SplintsRY
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- Withdrawn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
- Splints
- Model / reference
- 15*92CM、11*100CM、11*92CM、11*91CM、11*90CM、11*72CM、11*71CM、11*62CM、11*61CM、11*46CM、11*45CM、11*23CM、11*25CM、4.5*9.5CM or customized, 4.5*9.5CM
- Primary DI / UDI-DI
- 06978729270339
- Basic UDI-DI
- 697872927SplintsRY
- EMDN code
- M030505 Zimmer splints
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048036
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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