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Plastic Bib Chain

by Mark One Surgical

Ref D-141-293Model DENTAL X-RAY HOLDER

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number896110404XRAY/HOLCLASSINZ Basic UDI-DI 08961104044555UDI-DIDate23 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
DENTAL X-RAY HOLDER, D-141-293
Primary DI / UDI-DI
08961104044555
Basic UDI-DI
896110404XRAY/HOLCLASSINZ
EMDN Code
L150703 Orthodontic cutters, reusable
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
PK-MF-000031202
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: 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