ProLine PercuTrach® Suction, Gr.7 mit atraumatischer Einführhilfe steril, nicht…

EUDAMED

Class IIb (EU MDR)

Ref 1021370Model ProLine und Optima PercuTrach Sets

by Primed Halberstadt Medizintechnik GmbH

Identity

Trade Name: ProLine PercuTrach® Suction, Gr.7 mit atraumatischer Einführhilfe steril, nicht MRT geeignet EUDAMED
Model / Reference: ProLine und Optima PercuTrach Sets EUDAMED
1021370 EUDAMED

Identifiers

Primary DI / UDI-DI: 04250203258791 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 PercuTrach® Suction, Gr.7 mit atraumatischer Einführhilfe steril, nicht… by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED

Shiley — Covidien LP · Class II
TRACOE mini — Tracoe medical GmbH · Class II
Tracheal Stent with Mesh and Posts — HOOD, E BENSON LABORATORIES INC · Class II
Shiley — Covidien LP · Class II
Silber Innenkanüle mit Adaptionsring für rundes Kastenventil gesiebt — Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH · Class IIb
TRACOE silcosoft — Tracoe medical GmbH · Class II
Shiley — Covidien LP · Class II
Shiley — Covidien LP · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

EUDAMED a71e11d4-cf2b-4f09-af1d-96550f9bbade 61 fields · synced Oct 6, 2026