Identity
- Trade Name
- ENDOTRACHEAL TUBE-CUFFED EUDAMED
- Device Name
- Endotracheal Tube EUDAMED
- Model / Reference
- GS-2004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120200457 EUDAMED08902120200440 EUDAMED08902120200419 EUDAMED08902120200402 EUDAMED08902120200488 EUDAMED08902120200433 EUDAMED
- Basic UDI-DI
- 8902120B001RF EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT 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: Basic endotracheal tube, single-use
Endotracheal Tube-Cuffed by Romsons International (Unit II) — 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 | 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 (6)
- EUDAMED 0f26b22f-1eac-4002-a1c7-7e715b4ccf79 61 fields · synced Sep 18, 2026
- EUDAMED 16c20b2d-ff56-4b76-8991-a274760f291b 61 fields · synced May 18, 2026
- EUDAMED 6c4f38b7-712e-483c-90f2-d9e44d57d3bb 61 fields · synced May 19, 2026
- EUDAMED d6bcec7b-8061-46dd-888f-88b4181a78b4 61 fields · synced May 19, 2026
- EUDAMED 4664112e-8526-415b-a359-92fe0f28c0bc 61 fields · synced May 19, 2026
- EUDAMED a01f6825-fd1b-441c-a60a-6860a0e69a46 61 fields · synced May 19, 2026