Identity
- Trade Name
- ENDOTRACHEAL TUBE-RE-INFORCED-CUFFED EUDAMED
- Device Name
- Endotracheal Tube EUDAMED
- Model / Reference
- GS-2013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120201393 EUDAMED08902120201355 EUDAMED08902120201379 EUDAMED08902120201348 EUDAMED08902120201362 EUDAMED08902120201317 EUDAMED08902120201324 EUDAMED
- Basic UDI-DI
- 8902120B001RF EUDAMED
- EMDN Code
- R01030202 ENDOTRACHEAL TUBES, CUFFED, REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Endotracheal Tube-Re-Inforced-Cuffed by Romsons International (Unit II) — 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 | 8902120B001RF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (7)
- EUDAMED adfdfee6-345e-473c-b8ea-c69bb953bd6a 61 fields · synced Oct 1, 2026
- EUDAMED ffb12872-c608-4237-a184-d8665c0ca22e 61 fields · synced May 17, 2026
- EUDAMED 5736d689-3687-428f-bd4a-7169fdd7a118 61 fields · synced May 19, 2026
- EUDAMED 1371a161-02e0-40d3-98e5-85d1bf719088 61 fields · synced May 19, 2026
- EUDAMED 98b34d38-e7a9-46c3-9489-85e0e4af1bea 61 fields · synced May 19, 2026
- EUDAMED 9ba6d511-950c-4931-90a1-24d424861aaf 61 fields · synced May 19, 2026
- EUDAMED 6de83a21-d5d9-433b-8e7f-0ffe610329db 61 fields · synced May 19, 2026