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MIS Uniplane Screw, 80mm

by Boneunion (Xiamen) Medical Device Co., Ltd. 45 variants

Ref 3240055540

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06941273203344 Basic UDI-DI 06941273203344UDI-DIDate27 Oct 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  • Withdrawn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
MIS Uniplane Screw, 80mm
Model / Reference
3240055540
Primary DI / UDI-DI
06941273203344
Basic UDI-DI
B-06941273203344
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000022385
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Boneunion (Xiamen) Medical Device Co., Ltd.

See all devices from Boneunion (Xiamen) Medical Device Co., Ltd. →

Properties

  • Implantable
  • Reprocessed

Other properties (9)

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