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Trachealkanüle Optima Voice Cuff Standard Gr.6, dehp-frei
EUDAMEDClass IIb (EU MDR)
Ref 102043Model Trachealkanüle
Identity
- Trade Name
- Trachealkanüle Optima Voice Cuff Standard Gr.6, dehp-frei EUDAMED
- Device Name
- Optima, Ultrasoft, ProLine EUDAMED
- Model / Reference
- Trachealkanüle EUDAMED102043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250203214834 EUDAMED
- Basic UDI-DI
- 42502032PRI0624W EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Trachealkanüle Optima Voice Cuff Standard Gr.6, dehp-frei by Primed Halberstadt Medizintechnik GmbH — Class IIb — MDR — listed in EUDAMED
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Manufacturer's product page: PRIMEDISTOM® Trachealkanülen mit Cuff
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 | 42502032PRI0624W | Class IIb | Active |
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Manufacturer
- Manufacturer
- Primed Halberstadt Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000004967
Sources (1)
- EUDAMED 7837f1a3-919d-47c1-bc6e-359edf9b5482 61 fields · synced Oct 6, 2026