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KALEIDO MANDIBLE U-Plate, small, 41.9*204.8mm, Thickness 2.5mm, 4+20+4 Holes

by Shenzhen World Surgery Medical Device Technology Co., Ltd.

Ref 2A1114122501Model U shape bone plate

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06950292630277 Basic UDI-DI 06950292630277UDI-DIDate5 Mar 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  • Withdrawn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
KALEIDO MANDIBLE U-Plate, small, 41.9*204.8mm, Thickness 2.5mm, 4+20+4 Holes
Model / Reference
U shape bone plate, 2A1114122501
Primary DI / UDI-DI
06950292630277
Basic UDI-DI
B-06950292630277
EMDN Code
P09120501 Osteosynthesis compression plates
Device Class
Class IIb
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000017319
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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