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Dexter

by Distalmotion SA Switzerland EUDAMED

Ref 516Model Dexter L6

EMDN K01020299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764018484IN-N102A2 Basic UDI-DIDate23 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • HU24/00000124 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    18 Nov 2025
    Expires
    15 Oct 2029
    Reason
    Add device or group

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Needle Holder
Model / Reference
Dexter L6, 516
Primary DI / UDI-DI
07640184840561
Basic UDI-DI
764018484IN-N102A2
EMDN Code
K01020299 Robotic surgery instrument, single-use - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000037226
Authorised representative
Distalmotion Deutschland GmbH DE-AR-000046740

Other devices from Distalmotion SA

See all devices from Distalmotion SA →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 84972dd1-d785-4d66-b077-020a6188cacc 61 fields · synced 22 Oct 2026