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PercuTrach® PDT-Set Typ 2 + Optima Basic Cuff, Gr.8 steril
EUDAMEDClass IIb (EU MDR)
Ref 112325Model ProLine und Optima PDT Sets
Identity
- Trade Name
- PercuTrach® PDT-Set Typ 2 + Optima Basic Cuff, Gr.8 steril EUDAMED
- Model / Reference
- ProLine und Optima PDT Sets EUDAMED112325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250203220460 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
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
PercuTrach® PDT-Set Typ 2 + Optima Basic Cuff, Gr.8 steril by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED
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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 7cdfc323-ab37-4fae-8060-4d8be059f614 61 fields · synced Oct 6, 2026