Identity
- Trade Name
- ROMO VAC SET® MAXI EUDAMED
- Device Name
- CLOSED WOUND DRAINAGE SYSTEM EUDAMED
- Model / Reference
- GS-5002 F EUDAMEDGS-5002 F KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265002928 EUDAMED08907265013269 EUDAMED08907265013252 EUDAMED08907265002874 EUDAMED08907265013214 EUDAMED08907265013191 EUDAMED08907265013221 EUDAMED08907265002881 EUDAMED08907265013238 EUDAMED08907265013245 EUDAMED08907265002898 EUDAMED08907265002942 EUDAMED08907265002904 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® Maxi 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 (13)
- EUDAMED 1350c553-898f-48be-b292-7b675bd9cf0d 61 fields · synced Oct 5, 2026
- EUDAMED bf957eac-298a-4e64-9f35-15c66e35b74f 61 fields · synced May 16, 2026
- EUDAMED 241bc064-57fb-471e-a98a-1a8686a13908 61 fields · synced May 16, 2026
- EUDAMED 39d8e46c-0a92-40c7-ad12-b099d4f8aa0c 61 fields · synced May 17, 2026
- EUDAMED dc030193-c04a-41c9-bedd-70059795dcbb 61 fields · synced May 17, 2026
- EUDAMED ed4277f2-4ee5-4d21-b13d-35325cac81a5 61 fields · synced May 18, 2026
- EUDAMED 41b8eb66-3a86-4b58-b6da-c8e63dddb049 61 fields · synced May 19, 2026
- EUDAMED 8aa84114-8220-4234-9c81-3caa201d22e1 61 fields · synced May 19, 2026
- EUDAMED f602819b-698b-4da3-93ef-6b8b35737dd7 61 fields · synced May 19, 2026
- EUDAMED 0128eaf4-d683-408a-8e4b-1b86a1652ca5 61 fields · synced May 19, 2026
- EUDAMED 8ad05627-7ce5-47d2-acb5-cff3b8d78d43 61 fields · synced May 19, 2026
- EUDAMED bda70bee-6c90-4a53-a302-d9df1aaeff3c 61 fields · synced May 19, 2026
- EUDAMED 857f2424-3f27-4902-995a-137b8964c825 61 fields · synced May 19, 2026