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Canwell

by Canwell Medical Co., Ltd. 1,000+ variants

Ref 122247006

Active European Union

CE MDR

Valid until

1 Mar 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

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 Number6142788CE02 Date19 Oct 2026IssuedStatusActive expires 1 Mar 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6142788CE02 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    19 Oct 2026
    Expires
    1 Mar 2029
    Reason
    Add device or group
  • 6142788CE02 Active Amended Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    26 May 2026
    Expires
    1 Mar 2029
    Reason
    Ar data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Metal Bone Plate
Model / reference
122247006
Primary DI / UDI-DI
06942980250140
Basic UDI-DI
69429802KH0001GB
EMDN code
P09120501 Osteosynthesis compression plates
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

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

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Properties

  • Sterilise before use
  • Implantable
  • Sutures

Other properties (12)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No