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PRIMEDISILK® T-Tubus, Gr. 11, steril

EUDAMED

Class IIa (EU MDR)

Ref 200643Model T-Tuben

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name
PRIMEDISILK® T-Tubus, Gr. 11, steril EUDAMED
Model / Reference
T-Tuben EUDAMED
200643 EUDAMED

Identifiers

Primary DI / UDI-DI
04250203221191 EUDAMED
Basic UDI-DI
42502032PRI05959 EUDAMED
EMDN Code
R0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

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

PRIMEDISILK® T-Tubus, Gr. 11, steril by Primed Halberstadt Medizintechnik GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

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

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 64a7e63c-7d85-4da0-b041-8c39fac8c49e 61 fields · synced Oct 6, 2026