Identity
- Trade Name
- ENDOTRACHEAL TUBE CUFFED EUDAMED
- Device Name
- ENDOTRACHEAL TUBE EUDAMED
- Model / Reference
- GS-2004 KAD EUDAMEDGS-2004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265010428 EUDAMED08907265000153 EUDAMED08907265010473 EUDAMED08907265010503 EUDAMED08907265010435 EUDAMED08907265011630 EUDAMED08907265010404 EUDAMED08907265010480 EUDAMED08907265010497 EUDAMED08907265200430 EUDAMED08907265200454 EUDAMED08907265011661 EUDAMED08907265200409 EUDAMED08907265010442 EUDAMED08907265010459 EUDAMED08907265010466 EUDAMED08907265000399 EUDAMED08907265000412 EUDAMED08907265001075 EUDAMED
- Basic UDI-DI
- 8907265B001YA EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT 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: Basic endotracheal tube, single-use
Endotracheal Tube Cuffed by Romsons Group Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Basic endotracheal tube, single-use.
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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 (19)
- EUDAMED 2bd68415-9b9c-4b95-882f-13a142927d89 61 fields · synced Oct 5, 2026
- EUDAMED 57172c8e-d388-4ecf-bc79-bf9abab5ffc5 61 fields · synced May 11, 2026
- EUDAMED 618e6691-ecdd-4911-acb3-1c4f77fef412 61 fields · synced May 16, 2026
- EUDAMED 1d98c654-c367-4635-8601-6e3a07b37aee 61 fields · synced May 17, 2026
- EUDAMED 74505f48-b25d-411b-868b-866a453ff15a 61 fields · synced May 17, 2026
- EUDAMED b589288f-e0cc-471e-a2ca-569d469610d6 61 fields · synced May 17, 2026
- EUDAMED b7469524-8081-4b47-974e-20838d4cacae 61 fields · synced May 17, 2026
- EUDAMED 82f9c685-3b43-4379-936c-f1e9b2331456 61 fields · synced May 17, 2026
- EUDAMED 64d92977-e0e8-4da2-9cf8-759ec155b861 61 fields · synced May 17, 2026
- EUDAMED 8b98c96c-d132-4a47-80af-34ce04269371 61 fields · synced May 17, 2026
- EUDAMED 0ea6903c-03d6-4ac7-9438-b6b35ea7584c 61 fields · synced May 19, 2026
- EUDAMED 89f41ea8-fbd0-4da0-9f23-b3494bf1056b 61 fields · synced May 19, 2026
- EUDAMED dbdc3678-63b8-4a35-821d-9b5c97471e56 61 fields · synced May 19, 2026
- EUDAMED cfefe6ee-4a4a-4cfd-a5e5-c92016c82b79 61 fields · synced May 19, 2026
- EUDAMED 63a88030-f7a4-49b1-8c35-fd4128c0f257 61 fields · synced May 19, 2026
- EUDAMED 24838709-5f2c-4b95-9d68-3701a582e286 61 fields · synced May 19, 2026
- EUDAMED 734dd51e-3e38-4e47-8f6e-d4dc48ea3355 61 fields · synced May 19, 2026
- EUDAMED 27ebfc2b-0282-4531-be99-92633a6c175d 61 fields · synced May 19, 2026
- EUDAMED 14c01c8c-5866-4354-9a44-5656d3d5de03 61 fields · synced May 19, 2026