Identity
- Trade Name
- ROMO VAC SET® MIDI EUDAMED
- Device Name
- CLOSED WOUND DRAINAGE SYSTEM EUDAMED
- Model / Reference
- GS-5002 M KAD EUDAMEDGS-5002 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265013276 EUDAMED08907265013313 EUDAMED08907265013344 EUDAMED08907265002973 EUDAMED08907265013306 EUDAMED08907265013320 EUDAMED08907265002997 EUDAMED
- Basic UDI-DI
- 8907265G001ZD EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR 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
Romo Vac Set® Midi 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 | 8907265G001ZD | 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 (7)
- EUDAMED 58fd68b7-912d-4723-aeb2-eeeaea3c43eb 61 fields · synced Sep 18, 2026
- EUDAMED 694d54d7-2889-4c95-a424-b973bcd247eb 61 fields · synced May 17, 2026
- EUDAMED 02cd6b7e-ac66-4419-94cb-cd302df7cbb9 61 fields · synced May 17, 2026
- EUDAMED 9716d591-5bd6-4647-8d33-fe148d4bea86 61 fields · synced May 17, 2026
- EUDAMED 76297486-428e-4878-963a-f3d4ceed8cb3 61 fields · synced May 17, 2026
- EUDAMED 5c8c3f8f-20e4-47f3-a235-73e948922cd7 61 fields · synced May 18, 2026
- EUDAMED b01fad0c-00e3-4bd7-8722-4efefb75c3e5 61 fields · synced May 19, 2026