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Fahnestock Knife with Plastic Handle

by Mark One Surgical EUDAMED

Active European Union

Ref D-119-822Model Knives

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number896110404KNIVES/CLASSI6E Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Gingivectomy Knives Orban Fig. 1
Model / Reference
Knives, D-119-822
Primary DI / UDI-DI
08961104044333
Basic UDI-DI
896110404KNIVES/CLASSI6E
EMDN Code
L159013 Dental spatulas, reusable
Device Class
Class I
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