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Medical External Fixation Device

by Shenzhen Leihu Medical Equipment Manufacturing Co. Ltd

Ref LH-RS-17CM×19CM×20CMModel LH-RS-17CM×19CM×20CM LH-RS-28CM×21CM×24CM LH-RS-31CM×24CM×24CM LH-RS-35CM×28CM×25CM LH-ZH-24CM×26CM×90° LH-ZH-27CM×29CM×90° LH-ZH-30CM×32CM×90° LH-ZH-33CM×29CM×90° 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 Number697136216SZLH001XS Basic UDI-DI 06971362160005UDI-DIDate3 Mar 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  • Withdrawn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
Medical External Fixation Device
Model / Reference
LH-RS-17CM×19CM×20CM LH-RS-28CM×21CM×24CM LH-RS-31CM×24CM×24CM LH-RS-35CM×28CM×25CM LH-ZH-24CM×26CM×90° LH-ZH-27CM×29CM×90° LH-ZH-30CM×32CM×90° LH-ZH-33CM×29CM×90° etc, LH-RS-17CM×19CM×20CM
Primary DI / UDI-DI
06971362160005
Basic UDI-DI
697136216SZLH001XS
EMDN Code
Y090699 Devices for body protection - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000044870
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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