Identity
- Trade Name
- Urine bag EUDAMED
- Device Name
- Urine bag EUDAMED
- Model / Reference
- 1000~2000ML EUDAMEDUR062500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013961040 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSUB0017A EUDAMED
- Direct Marketing DI
- 06972013961040 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 (2)
- EUDAMED 161b6e38-2b52-45ec-8b62-b20377aa788d 61 fields · synced Jun 19, 2026
- EUDAMED db33247c-0f32-4347-83df-38ccaf99e92a 61 fields · synced Jun 19, 2026