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Bojin

by Shanghai Bojin Medical Instrument Co., Ltd China EUDAMED

Ref BJ5600Model BYJZ-I, BYJ-I, BYZ-I, BYJ-II, BYZ-II

EMDN Z12130501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06973011521342 Basic UDI-DIDate25 Jan 2024RegisteredStatusActive
European UnionCE/MDD NumberB-06973011521342 Basic UDI-DIDate25 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Medical electrical saw drills
Model / Reference
BYJZ-I, BYJ-I, BYZ-I, BYJ-II, BYZ-II, BJ5600
Primary DI / UDI-DI
06973011521342
Basic UDI-DI
B-06973011521342, 69730115BYJZU2
EMDN Code
Z12130501 Motorised orthopaedic surgery systems
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000020042
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai Bojin Medical Instrument Co., Ltd.

See all devices from Shanghai Bojin Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED b0e3acd3-5f5b-4078-92ed-5c036914476a 61 fields · synced 22 Oct 2026
  • EUDAMED 06973011521342|69730115BYJZU2 61 fields · synced 18 May 2026