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Medical External Fixation Device

by Leihu (Henan) Medical Devices Co., Ltd. 15 variants

Ref LH-A101-MModel LH-RS-17CM×19CM×20CM，LH-RS-28CM×21CM×24CM，LH-RS-31CM×24CM×24CM，LH-RS-35CM×28CM×25CM

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697906358LHRSUS Basic UDI-DI 06979063584502UDI-DIDate10 Dec 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  • Withdrawn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

Model / Reference
LH-RS-17CM×19CM×20CM，LH-RS-28CM×21CM×24CM，LH-RS-31CM×24CM×24CM，LH-RS-35CM×28CM×25CM, LH-A101-M
Primary DI / UDI-DI
06979063584502
Basic UDI-DI
697906358LHRSUS
Direct Marketing DI
06979063584502
EMDN Code
Y090699 Devices for body protection - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000050787
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Leihu (Henan) Medical Devices Co., Ltd.

See all devices from Leihu (Henan) Medical Devices 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