Identity
- Trade Name
- ROMO-ADK EUDAMED
- Device Name
- SURGICAL SUCTION / DRAINAGE DEVICES EUDAMED
- Model / Reference
- GS-5036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265503616 EUDAMED08907265503623 EUDAMED08907265503647 EUDAMED08907265503609 EUDAMED
- Basic UDI-DI
- 8907265G007ZR 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-Adk 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 | 8907265G007ZR | 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 (4)
- EUDAMED c7550e84-773e-4fe4-a723-29417373f8da 61 fields · synced Jul 28, 2026
- EUDAMED cc5a2ab6-2077-4ab9-93fb-501ecd8d4a1a 61 fields · synced May 17, 2026
- EUDAMED 5363f704-9f58-44e4-8916-406789b11e22 61 fields · synced May 19, 2026
- EUDAMED d6d40a01-cb74-454d-a88e-17a5d2add9d3 61 fields · synced May 19, 2026