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Orthopedic Splint

by Tianjin Chenhai Medical instrument Co., Ltd.

Ref Fiberglass fiber type -210/5.0cmx25cmModel Fiberglass fiber type: 210/5.0cmx25cm,312/7.5cmx30cm,313/7.5cmx33cm,314/7.5cmx35cm,315/7.5cmx38cm,320/7.5cmx50cm,322/7.5cmx55cm,335/7.5cmx90cm,412/10.0cmx30cm,415/10.0cmx40cm,417/10.0cmx43cm,418/10.0cmx45cm, etc

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697880652SPLINT001EX Basic UDI-DI 06978806523006UDI-DIDate27 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Orthopedic Splint
Model / Reference
Fiberglass fiber type: 210/5.0cmx25cm, 312/7.5cmx30cm, 313/7.5cmx33cm, 314/7.5cmx35cm, 315/7.5cmx38cm, 320/7.5cmx50cm, 322/7.5cmx55cm, 335/7.5cmx90cm, 412/10.0cmx30cm, 415/10.0cmx40cm, 417/10.0cmx43cm, 418/10.0cmx45cm, etc, Fiberglass fiber type -210/5.0cmx25cm
Primary DI / UDI-DI
06978806523006
Basic UDI-DI
697880652SPLINT001EX
EMDN Code
Y0699 External prostheses and orthoses - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048386
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Chenhai Medical instrument Co., Ltd.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No