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Extra Tracflex Plus Tracheostomy Size 10
EUDAMEDClass IIb (EU MDR)
Ref 120214-000100Ref 858150-000100
Identity
- Trade Name
- EXTRA TRACFLEX PLUS TRACHEOSTOMY SIZE 10 EUDAMED
- Device Name
- RÜSCH Extra Tracflex (cuff only) EUDAMED
- Model / Reference
- 120214-000100 EUDAMED858150-000100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704739049 EUDAMED14026704739087 EUDAMED
- Basic UDI-DI
- 08019020000000000000183KT EUDAMED
- Direct Marketing DI
- 44026704739040 EUDAMED44026704739088 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 10 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 (2)
- EUDAMED 7a17ca1e-0879-4047-9bde-fad2b2353cee 61 fields · synced Jul 23, 2026
- EUDAMED 72eb773f-da1b-4054-a1c8-29bfe4ff6120 61 fields · synced May 19, 2026