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iKey

by Beijing iKey Medical Device Technology Co., Ltd. 14 variants

Ref A000577

Active European Union

CE MDD

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/MDD NumberB-06932172512835 Basic UDI-DI 06932172512835UDI-DIDate30 Jul 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Bone Screws
Model / Reference
A000577
Primary DI / UDI-DI
06932172512835
Basic UDI-DI
B-06932172512835
EMDN Code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000008526
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Beijing iKey Medical Device Technology Co., Ltd.

See all devices from Beijing iKey Medical Device Technology Co., Ltd. →

Properties

  • Implantable

Other properties (10)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No