Identity
- Trade Name
- TRACHEOSTOMY TUBE PLAIN EUDAMED
- Device Name
- TRACHEOSTOMY TUBE EUDAMED
- Model / Reference
- GS-2008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265200829 EUDAMED08907265200836 EUDAMED08907265200850 EUDAMED08907265200812 EUDAMED08907265002089 EUDAMED08907265200881 EUDAMED08907265002096 EUDAMED08907265002102 EUDAMED08907265200874 EUDAMED08907265200867 EUDAMED
- Basic UDI-DI
- 8907265B007YN EUDAMED
- EMDN Code
- R0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS 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: Tracheostomy tube, non-reinforced, non-customized, single-use
Tracheostomy Tube Plain by Romsons Group Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8907265B007YN | 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 (10)
- EUDAMED d3f467a4-cdaf-4676-bf39-2aeb6736a5e0 61 fields · synced Jul 26, 2026
- EUDAMED 11479a03-bb29-4df6-b986-f09cd18f63d4 61 fields · synced May 17, 2026
- EUDAMED ab24ea25-6801-48e7-aa6d-6e03eb867eea 61 fields · synced May 18, 2026
- EUDAMED 43dbd236-2291-40a5-a231-400be09f0c98 61 fields · synced May 19, 2026
- EUDAMED e5bfc4ae-c002-49cf-9b76-e9572dcf360c 61 fields · synced May 19, 2026
- EUDAMED 8c00bb16-ebe1-4dc7-8ef6-6ceefa308c58 61 fields · synced May 19, 2026
- EUDAMED 06dde5cd-2e97-4c01-a3bb-d67bbbd75f14 61 fields · synced May 19, 2026
- EUDAMED dbb8400e-5e38-410a-a636-dd5b920f9a07 61 fields · synced May 19, 2026
- EUDAMED e94b6e5a-0591-4a2c-aa31-59704b8c8c4e 61 fields · synced May 19, 2026
- EUDAMED aa67c263-2129-48fb-88f6-691dcf7ec4a2 61 fields · synced May 19, 2026