Identity
- Trade Name
- URINE COLLECTION BAG EUDAMED
- Device Name
- Urine Collection Bag EUDAMED
- Model / Reference
- GS-1020 R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120102089 EUDAMED
- Basic UDI-DI
- 8902120A008RN EUDAMED
- EMDN Code
- A06030302 HOURLY DIURESIS MEASUREMENT SETS EUDAMED
Classification
- Device Class
- Class I 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
Urine Collection Bag by Romsons International (Unit II) — Class I — 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 | 8902120A008RN | Class I | 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 (1)
- EUDAMED bd095dbe-bce1-493b-a1ea-0a55b72412d8 61 fields · synced Jun 19, 2026