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Extra Tracflex Plus Tracheostomy Size 9
EUDAMEDClass IIb (EU MDR)
Ref 858150-000090Ref 120214-000090
Identity
- Trade Name
- EXTRA TRACFLEX PLUS TRACHEOSTOMY SIZE 9 EUDAMED
- Device Name
- RÜSCH Extra Tracflex (cuff only) EUDAMED
- Model / Reference
- 858150-000090 EUDAMED120214-000090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704739070 EUDAMED14026704739032 EUDAMED
- Basic UDI-DI
- 08019020000000000000183KT EUDAMED
- Direct Marketing DI
- 44026704739071 EUDAMED44026704739033 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 9 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 a1f6b279-9894-4020-96c9-68c4a3698569 61 fields · synced Sep 17, 2026
- EUDAMED 9a38f107-42c8-4ee1-90a1-bde10a1e7ec9 61 fields · synced May 18, 2026