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Trachealkanüle Optima Suction Standard Gr.6, dehp-frei

EUDAMED

Class IIb (EU MDR)

Ref 102053Model Trachealkanüle

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name
Trachealkanüle Optima Suction Standard Gr.6, dehp-frei EUDAMED
Device Name
Optima, Ultrasoft, ProLine EUDAMED
Model / Reference
Trachealkanüle EUDAMED
102053 EUDAMED

Identifiers

Primary DI / UDI-DI
04250203214889 EUDAMED
Basic UDI-DI
42502032PRI0624W EUDAMED
EMDN Code
R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, 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

Trachealkanüle Optima Suction Standard Gr.6, dehp-frei by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED

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 22206fac-2d8e-4245-8b09-054f641516c7 61 fields · synced Jul 12, 2026