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Dystraktor Podniebienny

by ChM spółka z ograniczoną odpowiedzialnością 18 variants

Ref 3.4499.035Model TRANSPALATAL DISTRACTOR

Active European Union

CE MDR

Valid until

30 Dec 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59084474NSP1VX Basic UDI-DIDate15 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Dystraktor Podniebienny
Model / Reference
TRANSPALATAL DISTRACTOR, 3.4499.035
Primary DI / UDI-DI
05908447341623
Basic UDI-DI
59084474NSP1VX
EMDN Code
P09120403 Osteosynthesis distractors
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000002121

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Properties

  • Implantable

Other properties (13)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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