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Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.8

by Primed Halberstadt Medizintechnik GmbH 14 variants

Ref 201305 uModel Trachealkanüle

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 linked in EUDAMED

A group certificate may exist

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 Number42502032PRI06452 Basic UDI-DI 04250203239318UDI-DIDate30 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Primedistom
Model / Reference
Trachealkanüle, 201305 u
Primary DI / UDI-DI
04250203239318
Basic UDI-DI
42502032PRI06452
EMDN Code
R0105010101 Tracheostomic cannulas, cuffless, not reinforced, with fixed flange, and kits
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000004967

From the manufacturer

Manufacturer's product page: PRIMEDISTOM® Trachealkanülen mit Cuff

Other devices from Primed Halberstadt Medizintechnik GmbH

See all devices from Primed Halberstadt Medizintechnik GmbH →

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