Stoma® 6045.00: CE/MDR Class I, Storz am Mark GmbH

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number++ESAM0518V Basic UDI-DI +ESAM6045001UDI-DI	Date5 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number+ESAM6045001 UDI-DI	Date27 Aug 2020Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI ++ESAM0518V — open Devices and search for it

Across registries

2 registries list this device

EUDAMED Basic UDI-DI ++ESAM0518V registered 5 Oct 2026 Active
FDA GUDID UDI-DI +ESAM6045001 listed 27 Aug 2020 Listed

Timeline

2 dated events

27 Aug 2020 Listed FDA GUDID +ESAM6045001
5 Oct 2026 Registered EUDAMED ++ESAM0518V

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Drahtbiegezange, Young, 14cm EUDAMED
Stoma® GUDID
Generic name: Wire holding/twisting forceps
Model / Ref / Catalog: 6045.00, 32886 - Wire holding/twisting forceps (051)

Primary DI / UDI-DI: +ESAM6045001 EUDAMED
ESAM6045001 GUDID
Basic UDI-DI: ++ESAM0518V
Direct marketing DI: +ESAM6045000
FDA product code: JEX
EMDN code: L031399 General surgery forceps, reusable - other
GMDN term: Wire holding/twisting forceps

Device class: Class I
Regulation number: 872.4565
EU registration type: Standard device
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED +ESAM6045001	GUDID ESAM6045001

The registries describe this device under different primary UDI-DIs (EUDAMED lists +ESAM6045001; FDA GUDID lists ESAM6045001), so their flags are not compared.