Identity
- Trade Name
- Urine bag EUDAMED
- Device Name
- Urine bag EUDAMED
- Model / Reference
- 1000~2000ML EUDAMEDUR062000 EUDAMEDUR062001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960111 EUDAMED06972013960098 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSUB0017A EUDAMED
- Direct Marketing DI
- 06972013960111 EUDAMED06972013960098 EUDAMED
- EMDN Code
- W05010203 URINE COLLECTION, CONTAINERS EUDAMED
Classification
- Device Class
- Class I 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
Urine bag by Multigate Co., Ltd — 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 | 697201396MU01SNNNSUB0017A | Class I | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (3)
- EUDAMED 32c25418-40ca-43ae-b5b9-916dc2802cab 61 fields · synced Jul 28, 2026
- EUDAMED 901cde39-9c26-49d2-ad9e-37f712f919de 61 fields · synced May 18, 2026
- EUDAMED 2d90cd41-7298-461d-a82f-75e356f5ce9e 61 fields · synced Jul 28, 2026