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Stoma® 13325.00

by Storz am Mark GmbH

Ref 13325.00Model 44887 - Dental osteotome (047)

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++ESAM04796 Basic UDI-DI +ESAM13325001UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ESAM13325001 UDI-DI Date27 Aug 2020ListedStatusListed 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

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Handgriff für Sinutom-/Kondenser-Ansätze, Palti EUDAMED
Stoma® GUDID
Generic Name
Dental osteotome
Model / Ref / Catalog
13325.00, 44887 - Dental osteotome (047)
Primary DI / UDI-DI
+ESAM13325001 EUDAMED
ESAM13325001 GUDID
Basic UDI-DI
++ESAM04796
Direct Marketing DI
+ESAM13325000
FDA Product Code
EJB
EMDN Code
Z12139099 Various orthopaedic and traumatology instruments - other
GMDN Term
Dental osteotome
Device Class
Class I
Regulation Number
872.4565
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

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+ESAM13325001
GUDID
ESAM13325001

Related devices

Category: Dental osteotome

Other devices from Storz am Mark GmbH

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