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Romo-Seal
EUDAMEDClass IIa (EU MDR)
Ref GS-5020Ref GS-5031Ref GS-5031 KADRef GS-5032 KAD
Identity
- Trade Name
- ROMO-SEAL EUDAMED
- Device Name
- UNDER WATER SEAL DRAINAGE SYSTEM EUDAMED
- Model / Reference
- GS-5020 EUDAMEDGS-5031 EUDAMEDGS-5031 KAD EUDAMEDGS-5032 KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265502008 EUDAMED08907265503104 EUDAMED08907265010206 EUDAMED08907265010213 EUDAMED
- Basic UDI-DI
- 8907265G005ZM EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDAustria 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-Seal 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 | 8907265G005ZM | 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 675ff771-50fa-4267-b484-70b38c195e3d 61 fields · synced Sep 17, 2026
- EUDAMED b24d1975-5866-46bf-a97f-05c5f1db1bd1 61 fields · synced Jul 10, 2026
- EUDAMED b3ed40b3-19d8-4c2b-8510-43bf4a868243 61 fields · synced Jul 17, 2026
- EUDAMED 20f46279-2823-4d4d-ae71-005fbb875cd2 61 fields · synced Sep 17, 2026