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PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, Gr. 8 ohne Ösen/ without eyelets

EUDAMED

Class IIb (EU MDR)

Ref 200550Model Stoma Button

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name
PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, Gr. 8 ohne Ösen/ without eyelets EUDAMED
Model / Reference
Stoma Button EUDAMED
200550 EUDAMED

Identifiers

Primary DI / UDI-DI
04250203224604 EUDAMED
Basic UDI-DI
42502032PRI0604S 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

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

PRIMEDIBUTTON®, Stoma Button Typ II, ohne Ösen, Gr. 8 ohne Ösen/ without eyelets 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 ohne 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 f8331dd8-61b4-488e-ab3b-2d4495a445f8 61 fields · synced Jul 21, 2026