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Medical electrical saws

by Shanghai Bojin Medical Instrument Co., Ltd 2 variants

Ref BJ3401-IVModel BYJ-II 3401

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697301152BYJSGY Basic UDI-DI 06975069298047UDI-DIDate13 Sep 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Medical electrical saws
Model / Reference
BYJ-II 3401, BJ3401-IV
Primary DI / UDI-DI
06975069298047
Basic UDI-DI
697301152BYJSGY
Direct Marketing DI
06975069298047
EMDN Code
Z12130501 Motorised orthopaedic surgery systems
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000020042
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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

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

Properties

  • 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