Stoma® 6550.00

by Storz am Mark GmbH

Ref 6550.00Model 12143 - Instrument tray, reusable (004)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number++ESAM0048L Basic UDI-DI +ESAM6550001UDI-DI	Date5 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	Number+ESAM6550001 UDI-DI	Date27 Aug 2020Listed	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Withdrawn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: p.i.c.-tray, 271x175x34mm, leer EUDAMED
Stoma® GUDID
Generic Name: Instrument tray, reusable
Model / Ref / Catalog: 6550.00, 12143 - Instrument tray, reusable (004)

Primary DI / UDI-DI: +ESAM6550001 EUDAMED
ESAM6550001 GUDID
Basic UDI-DI: ++ESAM0048L
Direct Marketing DI: +ESAM6550000
FDA Product Code: FSM
EMDN Code: V0402 Clinical use trays and bowls
GMDN Term: Instrument tray, reusable

Device Class: Class I
Regulation Number: 878.4800
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED +ESAM6550001	GUDID ESAM6550001

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Properties

Reusable
Prescription Use
Premarket Exempt
Lot / Batch Number

Other properties (20)

Sterile: No
Single Use: No
Implantable: 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
Manufacturing Date: No