Identity
- Trade Name
- TRACHEOSTOMY TUBE-CUFFED EUDAMED
- Device Name
- Tracheostomy Tube EUDAMED
- Model / Reference
- GS-2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120201027 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-Cuffed 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 (1)
- EUDAMED a6213008-681b-487c-9830-6fd0457c61eb 61 fields · synced Jun 19, 2026