Identity
- Trade Name
- ENDOTRACHEAL TUBE RE-INFORCED-CUFFED EUDAMED
- Device Name
- ENDOTRACHEAL TUBE EUDAMED
- Model / Reference
- GS-2013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265201307 EUDAMED
- Basic UDI-DI
- 8907265B001YA EUDAMED
- EMDN Code
- R01030202 ENDOTRACHEAL TUBES, CUFFED, REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 Group Private Limited — 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 | 8907265B001YA | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED bdebc5a4-63a0-4614-bb8d-4b8bd049ebca 61 fields · synced Jun 18, 2026