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Romsons Percutaneous Tracheostomy Kit, Romo-Soft Cuff-Df
EUDAMEDClass IIa (EU MDR)
Ref GS-2103Ref GS-2102
Identity
- Trade Name
- ROMSONS PERCUTANEOUS TRACHEOSTOMY KIT, ROMO-SOFT CUFF-DF EUDAMEDROMO SOFT EUDAMED
- Device Name
- TRACHEOSTOMY TUBE EUDAMED
- Model / Reference
- GS-2103 EUDAMEDGS-2102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265210309 EUDAMED08907265002010 EUDAMED08907265002034 EUDAMED08907265210286 EUDAMED08907265210330 EUDAMED08907265210293 EUDAMED08907265210217 EUDAMED08907265210200 EUDAMED08907265002027 EUDAMED08907265210316 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
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Romsons Percutaneous Tracheostomy Kit, Romo-Soft Cuff-Df by Romsons Group Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tracheostomy tube, non-reinforced, non-customized, 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 | 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 b54d643a-eba1-4649-8668-f26c5f8453f3 61 fields · synced Aug 3, 2026
- EUDAMED ec8b0ca5-cb84-4ac0-ac03-7da53709de6b 61 fields · synced May 17, 2026
- EUDAMED 973e57df-7dc9-49f7-acb9-85aa0d82ac2f 61 fields · synced May 17, 2026
- EUDAMED d7298608-c435-4458-b59a-1ea4a10a796a 61 fields · synced May 17, 2026
- EUDAMED 5642804a-33b0-4277-883b-5d82ece8f2df 61 fields · synced May 17, 2026
- EUDAMED c2250027-7ed9-43fb-a6c1-c4a89e3f15b1 61 fields · synced May 17, 2026
- EUDAMED a1a4a215-eb54-4919-9310-77d1152bb6ac 61 fields · synced May 17, 2026
- EUDAMED bcdffdb3-3f54-46e9-b898-ed7c9581910f 61 fields · synced May 18, 2026
- EUDAMED 7f0a7f9a-3adb-45f5-b8c1-29fc645a34f7 61 fields · synced May 18, 2026
- EUDAMED 87530ccf-c6c6-4a26-b204-430108acabea 61 fields · synced May 19, 2026