Identity
- Trade Name
- ROMO-SEAL EUDAMED
- Device Name
- Under Water Seal Drainage System EUDAMED
- Model / Reference
- GS-5032 EUDAMEDGS-5031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120503206 EUDAMED08902120503107 EUDAMED
- Basic UDI-DI
- 8902120G005SS EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Romo-Seal by Romsons International (Unit II) — 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 | 8902120G005SS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b8d582fe-a699-46cc-884c-66354980b6f0 61 fields · synced Jul 21, 2026
- EUDAMED f152189b-5b95-4aa2-b667-40d987909e4c 61 fields · synced May 18, 2026