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Urine Collection Bag
EUDAMEDClass I (EU MDR)
Ref GS-1020T (NS)Ref GS-1020A (NS)Ref GS-1020TRef GS-1020A Ref GS-1020CRef GS-1020 R5 (NS)Ref GS-1020D (NS)Ref GS-1020DRef GS-1020 R4 (NS)Ref GS-1020C (NS)Ref GS-1020AH (NS)Ref GS-1020B (NS)Ref GS-1020 R5
Identity
- Trade Name
- URINE COLLECTION BAG EUDAMED
- Device Name
- Urine Collection Bag EUDAMED
- Model / Reference
- GS-1020T (NS) EUDAMEDGS-1020A (NS) EUDAMEDGS-1020T EUDAMEDGS-1020A EUDAMEDGS-1020C EUDAMEDGS-1020 R5 (NS) EUDAMEDGS-1020D (NS) EUDAMEDGS-1020D EUDAMEDGS-1020 R4 (NS) EUDAMEDGS-1020C (NS) EUDAMEDGS-1020AH (NS) EUDAMEDGS-1020B (NS) EUDAMEDGS-1020 R5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120102256 EUDAMED08902120102102 EUDAMED08902120102072 EUDAMED08902120102010 EUDAMED08902120102034 EUDAMED08902120102249 EUDAMED08902120102225 EUDAMED08902120102041 EUDAMED08902120102263 EUDAMED08902120102218 EUDAMED08902120102270 EUDAMED08902120102201 EUDAMED08902120102065 EUDAMED
- Basic UDI-DI
- 8902120A012RD EUDAMED8902120A008RN EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMEDA06030302 HOURLY DIURESIS MEASUREMENT SETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
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 | 8902120A012RD | 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 (13)
- EUDAMED 86347bcb-1beb-4650-a48b-cf029beec506 61 fields · synced Oct 1, 2026
- EUDAMED ed245b86-2f1b-49fd-b3bf-fc5066c479c0 61 fields · synced May 16, 2026
- EUDAMED be2dc926-fe5c-4a07-989c-989f2be38419 61 fields · synced May 17, 2026
- EUDAMED 80136f75-40a8-4508-8ab0-0105b966bbdc 61 fields · synced May 17, 2026
- EUDAMED ec12af07-7089-4c5d-98d5-da001ca7cbf1 61 fields · synced May 17, 2026
- EUDAMED 851407b5-3710-4faa-b931-7da2d1e38a97 61 fields · synced May 18, 2026
- EUDAMED fa5f6fc9-42b2-451e-920b-06baa4ea347d 61 fields · synced May 18, 2026
- EUDAMED e2fb0aa7-27ac-4369-81b9-7b3b3dbde897 61 fields · synced May 18, 2026
- EUDAMED cc6c9d69-4a19-483c-be4a-39ae2e2f058a 61 fields · synced May 18, 2026
- EUDAMED 83c355da-f817-47c0-b69f-93aaac67ad00 61 fields · synced May 18, 2026
- EUDAMED d43c3509-f15b-48a1-99ea-98dd681c370c 61 fields · synced May 18, 2026
- EUDAMED fd236ef6-40e1-4023-bdfa-9f4d1b04037c 61 fields · synced May 18, 2026
- EUDAMED 8123630f-6de6-4769-a1ee-cc096d602419 61 fields · synced May 19, 2026