Stoma® 22349.09

by Storz am Mark GmbH

Ref 22349.09Model 45714 - Fixture/appliance dental drill bit, reusable (052)

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 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++ESAM0528X Basic UDI-DI +ESAM22349091UDI-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+ESAM22349091 UDI-DI	Date7 Nov 2022Listed	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Withdrawn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: Trepanbohrer, Innenmaß 9mm, Außenmaß 10mm, m. Innenkühlung EUDAMED
Stoma® GUDID
Generic Name: Fixture/appliance dental drill bit, reusable
Model / Ref / Catalog: 22349.09, 45714 - Fixture/appliance dental drill bit, reusable (052)

Primary DI / UDI-DI: +ESAM22349091 EUDAMED
ESAM22349091 GUDID
Basic UDI-DI: ++ESAM0528X
FDA Product Code: EJL
EMDN Code: L1104 Bits for neurosurgery drills, reusable
GMDN Term: Fixture/appliance dental drill bit, reusable

Device Class: Class IIa EUDAMED
Class I GUDID
Regulation Number: 872.3240
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED +ESAM22349091	GUDID ESAM22349091
Device Class	EUDAMED Class IIa	GUDID Class I

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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