Identity
- Trade Name
- ENDOTRACHEAL TUBE RE-INFORCED-CUFFED EUDAMED
- Device Name
- ENDOTRACHEAL TUBE EUDAMED
- Model / Reference
- GS-2013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265201376 EUDAMED08907265201345 EUDAMED08907265000177 EUDAMED08907265000283 EUDAMED08907265001082 EUDAMED08907265201390 EUDAMED08907265201338 EUDAMED08907265001099 EUDAMED08907265000252 EUDAMED08907265000276 EUDAMED08907265201352 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
Endotracheal Tube Re-Inforced-Cuffed by Romsons Group Private Limited — Class IIa — 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 | 8907265B001YA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (11)
- EUDAMED a515467c-02fc-4bde-b25c-425f8137ae80 61 fields · synced Oct 5, 2026
- EUDAMED 87a6db48-e9bf-4338-89b1-807126747b48 61 fields · synced May 16, 2026
- EUDAMED 08cc4ac8-3198-4cb0-8401-d5cdad90fcfb 61 fields · synced May 16, 2026
- EUDAMED 7e5577fe-ac5c-42d8-b814-f62c9c4db541 61 fields · synced May 17, 2026
- EUDAMED 58221139-d602-4b0a-b040-313621e408be 61 fields · synced May 17, 2026
- EUDAMED 13550c37-6917-4846-98e0-074ad00709c6 61 fields · synced May 18, 2026
- EUDAMED 672e355d-3ce6-45bf-995a-af4a5fe187dc 61 fields · synced May 18, 2026
- EUDAMED ae5bea9b-cd03-4000-a874-9fd0228aac7a 61 fields · synced May 19, 2026
- EUDAMED fc68f796-a9ea-47e5-b57b-4213bcfe2cc2 61 fields · synced May 19, 2026
- EUDAMED 452309d6-9625-4c7d-ade4-cd62bccb33fd 61 fields · synced May 19, 2026
- EUDAMED b86b2020-abb4-43db-a65d-f96fe5be2c11 61 fields · synced May 19, 2026