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PercuTrach® PDT-Set Typ 1 + ProLine XT PercuTrach® Cuff, Gr.8 mit atraumatische…
EUDAMEDClass IIb (EU MDR)
Ref 1032280Model ProLine und Optima PDT Sets
Identity
- Trade Name
- PercuTrach® PDT-Set Typ 1 + ProLine XT PercuTrach® Cuff, Gr.8 mit atraumatischer Einführhilfe steril EUDAMED
- Model / Reference
- ProLine und Optima PDT Sets EUDAMED1032280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250203266789 EUDAMED
- Basic UDI-DI
- 42502032PRI08254 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
PercuTrach® PDT-Set Typ 1 + ProLine XT PercuTrach® Cuff, Gr.8 mit atraumatische… by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED
Manufacturer's product page: PDT SET Typ 1
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 | 42502032PRI08254 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Primed Halberstadt Medizintechnik GmbH
- EUDAMED SRN
- DE-PR-000036373
Sources (1)
- EUDAMED 04645d7a-cd84-4f70-9a84-da867875eb1b 61 fields · synced Jun 18, 2026