Stoma® 14745.28

by Storz am Mark GmbH

Ref 14745.28Model 12726 - Suturing needle holder, reusable (006)

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

CE MDR

Valid until

11 Apr 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number++ESAM0068Q Basic UDI-DI +ESAM14745281UDI-DI	Date5 Oct 2026Registered	StatusActive
European Union	CE/MDR EUDAMED	Number1000330398	Date25 Sep 2026Issued	StatusActive expires 11 Apr 2029
United States	GUDID listing GUDID	Number+ESAM14745281 UDI-DI	Date27 Aug 2020Listed	StatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

1000330398 Active Supplemented

Quality management system EU MDR

Certifier

DQS Medizinprodukte GmbH 0297

Issued
25 Sep 2026

Expires
11 Apr 2029

Reason
Add device or group

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Nadelhalter, Barraquer, TC, 2,0mm, gerade, 18cm EUDAMED
Stoma® GUDID
Generic Name: Suturing needle holder, reusable
Model / Ref / Catalog: 14745.28, 12726 - Suturing needle holder, reusable (006)

Primary DI / UDI-DI: +ESAM14745281 EUDAMED
ESAM14745281 GUDID
Basic UDI-DI: ++ESAM0068Q
Direct Marketing DI: +ESAM14745280
FDA Product Code: GDF
EMDN Code: L0205 Needle holders, reusable
GMDN Term: Suturing needle holder, 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 +ESAM14745281	GUDID ESAM14745281

Other devices from Storz am Mark GmbH

Kürette, Barnhart BH1-2, Ø 8mm

Class I
p.i.c.-tray, Basic Kit, Dr.Bergmann

Class I
Knochenspreizer, Memmingen

Class I
Knochenkürette mit Spülanschluss, Lucas, 3mm, gezahnt, DE

Class I
Dauer-Teflonfilter, f. Container 1/2, 2 Stk., f.ca. 1200 Sterilisationszyklen

Class I
Vorbohrer, Ø 1, 3mm x 15mm, WST

Class IIa

See all devices from Storz am Mark GmbH →

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