Optima PercuTrach® Voice Cuff, Gr.8 mit atraumatischer Einführhilfe steril, nic…

EUDAMED

Class IIb (EU MDR)

Ref 102435Model ProLine und Optima PercuTrach Sets

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name: Optima PercuTrach® Voice Cuff, Gr.8 mit atraumatischer Einführhilfe steril, nicht MRT geeignet EUDAMED
Model / Reference: ProLine und Optima PercuTrach Sets EUDAMED
102435 EUDAMED

Identifiers

Primary DI / UDI-DI: 04250203220378 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

Optima PercuTrach® Voice Cuff, Gr.8 mit atraumatischer Einführhilfe steril, nic… by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED

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Manufacturer's product page: OPTIMA 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 4f64c816-cdb8-4c4e-b6ca-1dbf67d4820e 61 fields · synced Oct 8, 2026