Identity
- Trade Name
- Uro Drain Tray Set for 5602SRMB EUDAMEDUro Drain Tray Set FDA UDI
- Generic Name
- Urological fluid funnel FDA UDI
- Device Name
- Uro Drain Tray Set EUDAMEDUro Drain Tray Set for 5602SRMB FDA UDI
- Model / Reference
- 08-095-08 EUDAMEDFDA UDI
- Description
- Uro Drain Tray Set for 5602SRMB FDA UDI
Identifiers
- Catalog Number
- 08-095-08 FDA UDI
- Primary DI / UDI-DI
- 04946329068290 EUDAMEDFDA UDI
- Basic UDI-DI
- 49463290208009UJ EUDAMED
- Direct Marketing DI
- 04946329068290 EUDAMED
- FDA Product Code
- GDC FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
- GMDN Term
- Urological fluid funnel FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 305 Millimeter FDA UDI
Category: Instrument transport trolley system
Uro Drain Tray Set for 5602SRMB by Mizuho Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 49463290208009UJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MIZUHO Corporation
- EUDAMED SRN
- JP-MF-000019215
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4c8f2bb1-cac6-4a71-b5bb-dc476f29299a 61 fields · synced Jun 18, 2026
- FDA UDI f18efe34-f928-4a1b-ab94-940d0ab7c6c7 36 fields · synced May 30, 2026