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Extra Tracflex Plus Tracheostomy Size 8
EUDAMEDClass IIb (EU MDR)
Ref 858150-000080
Identity
- Trade Name
- EXTRA TRACFLEX PLUS TRACHEOSTOMY SIZE 8 EUDAMED
- Device Name
- RÜSCH Extra Tracflex (cuff only) EUDAMED
- Model / Reference
- 858150-000080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704739063 EUDAMED
- Basic UDI-DI
- 08019020000000000000183KT EUDAMED
- Direct Marketing DI
- 44026704739064 EUDAMED
- EMDN Code
- R0105020202 TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Extra Tracflex Plus Tracheostomy Size 8 by Teleflex Medical — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 08019020000000000000183KT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (1)
- EUDAMED c5717bac-12a2-45ba-8bc0-965ada906bd3 61 fields · synced Jun 18, 2026