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Stoma® 12969.10

by Storz am Mark GmbH

Ref 12969.10Model 45713 - Periotome, reusable (053)

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

CE MDR

Valid until

No date given

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++ESAM0538Z Basic UDI-DI +ESAM12969101UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ESAM12969101 UDI-DI Date7 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
T-Tome, Elaskary, DE, Ø10mm EUDAMED
Stoma® GUDID
Generic name
Periotome, reusable
Model / Ref / Catalog
12969.10, 45713 - Periotome, reusable (053)
Primary DI / UDI-DI
+ESAM12969101 EUDAMED
ESAM12969101 GUDID
Basic UDI-DI
++ESAM0538Z
Direct marketing DI
+ESAM12969100
FDA product code
EMO
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Periotome, reusable
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

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+ESAM12969101
GUDID
ESAM12969101

Related devices

Category: Periotome, reusable

Other devices from Storz am Mark GmbH

See all devices from Storz am Mark GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number

Other properties (20)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No