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Tracflex Plus S Tracheostomy Tube Set
EUDAMEDClass IIb (EU MDR)
Ref 858163-000080
Identity
- Trade Name
- TRACFLEX PLUS S TRACHEOSTOMY TUBE SET EUDAMED
- Device Name
- RÜSCH Tracflex Plus S EUDAMED
- Model / Reference
- 858163-000080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704941480 EUDAMED
- Basic UDI-DI
- 08019020000000000000176KW EUDAMED
- Direct Marketing DI
- 44026704941481 EUDAMED
- EMDN Code
- R0105020201 TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH FIXED 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
Tracflex Plus S Tracheostomy Tube Set 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 | 08019020000000000000176KW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (1)
- EUDAMED 9c587ef0-168b-40b4-ac15-b8becf44f859 61 fields · synced Sep 30, 2026