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Splints

by Anping County Changtai Medical Equipment Factory 9 variants

Part of a family of 9 devices: see the family page

Ref 11*46CMModel 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 (11*46CM) 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 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697872927SplintsRY Basic UDI-DI 06978729270292UDI-DIDate2 Jun 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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, 11*46CM
Primary DI / UDI-DI
06978729270292
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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Properties

Other properties (14, all answered No)