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Canwell

by Canwell Medical Co., Ltd. EUDAMED

Active European Union

Ref 121222104

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6142788CE02 Date26 May 2026IssuedStatusActive expires 1 Mar 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6142788CE02 Amended

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    26 May 2026
    Expires
    1 Mar 2029
    Reason
    Ar data change

Specification

EUDAMED

Device Name
Metal Bone Plate
Model / Reference
121222104
Primary DI / UDI-DI
06942980231668
Basic UDI-DI
69429802KH0001GB
EMDN Code
P09120501 Osteosynthesis compression plates
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000025329
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Canwell Medical Co., Ltd

See all devices from Canwell Medical Co., Ltd →

Properties

Show properties
  • Implantable
  • Sutures
Other properties (12)
  • Sterile: 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