Uro Drain Tray Set for 3600 & 3500 Series, 5801

by MIZUHO Corporation

Ref 08-095-13

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number49463290208009UJ Basic UDI-DI 04946329185782UDI-DI	Date2 Sep 2025Registered	StatusActive
United States	GUDID listing GUDID	Number04946329185782 UDI-DI	Date15 Apr 2022Listed	StatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Uro Drain Tray Set for 3600 & 3500 Series, 5801 EUDAMED
Uro Drain Tray Set GUDID
Generic Name: Urological fluid funnel
Model / Ref / Catalog: 08-095-13

Primary DI / UDI-DI: 04946329185782
Basic UDI-DI: 49463290208009UJ
Direct Marketing DI: 04946329185782
FDA Product Code: GDC
EMDN Code: V0499 Clinical use containers (non-IVD) - other
GMDN Term: Urological fluid funnel

Device Class: Class I
Regulation Number: 878.4960
EU market of registration: Romania
GUDID distribution status: In Commercial Distribution

Size: Length — 370 Millimeter

Manufacturer details

EUDAMED SRN: JP-MF-000019215
Authorised representative: Emergo Europe B.V. NL-AR-000000116

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Properties

Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (20)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No