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Romsons Percutaneous Tracheostomy Kit, Romo-Soft Cuff-Wdf
EUDAMEDClass IIa (EU MDR)
Ref GS-2103 W
Identity
- Trade Name
- ROMSONS PERCUTANEOUS TRACHEOSTOMY KIT, ROMO-SOFT CUFF-WDF EUDAMED
- Device Name
- TRACHEOSTOMY TUBE EUDAMED
- Model / Reference
- GS-2103 W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265210354 EUDAMED
- Basic UDI-DI
- 8907265B007YN EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, 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
Romsons Percutaneous Tracheostomy Kit, Romo-Soft Cuff-Wdf by Romsons Group Private Limited — 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 | 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 (1)
- EUDAMED aff13a59-9297-4305-8e6c-897a41e92153 61 fields · synced Jun 18, 2026