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Shinva

by Xinhua Surgical Instrument Co., Ltd. China EUDAMED

Ref ZK477RB

EMDN L091202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69365063XHSI03WC Basic UDI-DIDate9 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Reusable Surgical Curettes/Elevators/Rongeurs/Chisels/Files/Bone levers
Model / Reference
ZK477RB
Primary DI / UDI-DI
06936894762165
Basic UDI-DI
69365063XHSI03WC
EMDN Code
L091202 Orthopaedic surgery files, reusable
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000038108
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from Xinhua Surgical Instrument Co., Ltd.

See all devices from Xinhua Surgical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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

Sources (1)

  • EUDAMED 06936894762165|69365063XHSI03WC 61 fields · synced 24 Oct 2026