Identity
- Trade Name
- TRACHEOSTOMY TUBE-PLAIN EUDAMED
- Device Name
- Tracheostomy Tube EUDAMED
- Model / Reference
- GS-2008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120200877 EUDAMED08902120200860 EUDAMED08902120200914 EUDAMED08902120200839 EUDAMED08902120200846 EUDAMED08902120200822 EUDAMED
- Basic UDI-DI
- 8902120B007RT EUDAMED
- EMDN Code
- R010503 TRACHEOSTOMY INNER CANNULAS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Tracheostomy Tube-Plain by Romsons International (Unit II) — 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 | 8902120B007RT | 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 0b623ce9-bcb5-4d5e-b6a4-1df3edf2517a 61 fields · synced Aug 4, 2026
- EUDAMED 2bcebbda-697a-40fa-8008-6a5b7d327596 61 fields · synced May 16, 2026
- EUDAMED 85d1ca4c-dcad-4ddb-b089-2ee4f4b9175e 61 fields · synced May 17, 2026
- EUDAMED 23b4215c-4751-47e7-b9c5-9de28245908e 61 fields · synced May 17, 2026
- EUDAMED 7a2381a1-eef7-4af3-b347-8ac6b0bee855 61 fields · synced May 19, 2026
- EUDAMED bb8b2352-a409-49aa-a134-93923146096c 61 fields · synced May 19, 2026