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Trachealkanüle ProLine XT Suction Gr. 10

EUDAMED

Class IIb (EU MDR)

Ref 1002310Model Trachealkanüle

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name
Trachealkanüle ProLine XT Suction Gr. 10 EUDAMED
Device Name
Optima, Ultrasoft, ProLine EUDAMED
Model / Reference
Trachealkanüle EUDAMED
1002310 EUDAMED

Identifiers

Primary DI / UDI-DI
04250203264310 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 ProLine XT Suction Gr. 10 by Primed Halberstadt Medizintechnik GmbH — Class IIb — 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 2c19c029-ca7f-4eb6-aa1f-aa1c49e4ed59 61 fields · synced Oct 5, 2026