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Laryngectomy tube, cuffed
EUDAMEDClass IIa (EU MDR)
Ref 121161-000090Ref 121161-000100
Identity
- Trade Name
- Laryngectomy tube, cuffed EUDAMED
- Device Name
- RÜSCH Laryngoflex EUDAMED
- Model / Reference
- 121161-000090 EUDAMED121161-000100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704761729 EUDAMED14026704761736 EUDAMED
- Basic UDI-DI
- 08019020000000000000177KY EUDAMED
- EMDN Code
- R01030202 ENDOTRACHEAL TUBES, CUFFED, REINFORCED EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Reinforced endotracheal tube, single-use
Laryngectomy tube, cuffed by Teleflex Medical — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Reinforced endotracheal tube, single-use.
- Rurka intubacyjna bez mankietu — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
- Disposable Tracheal tubes — Shaoxing Carere Medical Appliance Co., Ltd. · Class IIa
- Disposable Tracheal Tubes With Cuff — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- cuff — Contec Medical Systems Co., Ltd. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class II
- Welllead Reinforced Tracheal Tube — Well Lead Medical Co., Ltd · Class IIa
- Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa
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 | 08019020000000000000177KY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (2)
- EUDAMED c5c1b1eb-1476-41b8-a0ef-b0acd589e1ea 61 fields · synced Jul 24, 2026
- EUDAMED c666caf1-ccad-4d4a-84da-1665dd15f572 61 fields · synced May 18, 2026