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Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.13

EUDAMED

Class IIb (EU MDR)

Ref 201310 uModel Trachealkanüle

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name
Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.13 EUDAMED
Device Name
Primedistom EUDAMED
Model / Reference
Trachealkanüle EUDAMED
201310 u EUDAMED

Identifiers

Primary DI / UDI-DI
04250203239462 EUDAMED
Basic UDI-DI
42502032PRI06452 EUDAMED
EMDN Code
R0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Tracheostomy tube, non-reinforced, non-customized, single-use

Trachealkanüle PRIMEDISTOM® mit Sprechfunktion, Gr.13 by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED

Similar devices

Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.

Manufacturer's product page: PRIMEDISTOM® Trachealkanülen mit Cuff

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Primed Halberstadt Medizintechnik GmbH
EUDAMED SRN
DE-MF-000004967

Sources (1)

  • EUDAMED e2ab796f-6500-432c-9677-970736090cb8 61 fields · synced Jun 19, 2026