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PRIMEDISILK® T-Tubus, Gr. 12, steril

EUDAMED

Class IIa (EU MDR)

Ref 200644Model T-Tuben

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name
PRIMEDISILK® T-Tubus, Gr. 12, steril EUDAMED
Model / Reference
T-Tuben EUDAMED
200644 EUDAMED

Identifiers

Primary DI / UDI-DI
04250203221207 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. 12, 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

EUDAMED SRN
DE-MF-000004967

Sources (1)

  • EUDAMED 188268d4-be58-4174-93a7-83894be299d6 61 fields · synced Jul 26, 2026