ProLine XT PercuTrach® Cuff Voice, Gr.10 mit atraumatischer Einführhilfe steril…

EUDAMED

Class IIb (EU MDR)

Ref 1022510Model ProLine und Optima PercuTrach Sets

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name: ProLine XT PercuTrach® Cuff Voice, Gr.10 mit atraumatischer Einführhilfe steril, nicht MRT geeignet EUDAMED
Model / Reference: ProLine und Optima PercuTrach Sets EUDAMED
1022510 EUDAMED

Identifiers

Primary DI / UDI-DI: 04250203265645 EUDAMED
Basic UDI-DI: 42502032PRI0804Y EUDAMED
EMDN Code: R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Medical Purpose: Perkutane Dilatationstracheotomie EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Category: Tracheostomy tube, non-reinforced, non-customized, single-use

ProLine XT PercuTrach® Cuff Voice, Gr.10 mit atraumatischer Einführhilfe steril… by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED

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Manufacturer's product page: PROLINE (XT) PercuTrach®

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	42502032PRI0804Y	Class IIb	Active

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Manufacturer

Manufacturer: Primed Halberstadt Medizintechnik GmbH
EUDAMED SRN: DE-PR-000036373

Sources (1)

EUDAMED 5445be46-72d3-4e6f-8da5-351b841d4ec9 61 fields · synced Oct 8, 2026