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Stoma® 12965.00

by Storz am Mark GmbH

Ref 12965.00Model 45713 - Periotome, reusable (053)

Stoma® 12965.00 is a Class I device made by Storz am Mark GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI ++ESAM0538Z) and listed in FDA GUDID since 27 Aug 2020 (UDI-DI +ESAM12965001), active as of 24 Oct 2026.

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++ESAM0538Z Basic UDI-DI +ESAM12965001UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ESAM12965001 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++ESAM0538Z registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI +ESAM12965001 listed 27 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +ESAM12965001
  2. Registered EUDAMED ++ESAM0538Z

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  • Withdrawn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
Periotom, kniegebogen, Ø 8mm, SE EUDAMED
Stoma® GUDID
Generic name
Periotome, reusable
Model / Ref / Catalog
12965.00, 45713 - Periotome, reusable (053)
Primary DI / UDI-DI
+ESAM12965001 EUDAMED
ESAM12965001 GUDID
Basic UDI-DI
++ESAM0538Z
Direct marketing DI
+ESAM12965000
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
+ESAM12965001
GUDID
ESAM12965001

The registries describe this device under different primary UDI-DIs (EUDAMED lists +ESAM12965001; FDA GUDID lists ESAM12965001), so their flags are not compared.

Related devices

Category: Periotome, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Storz am Mark GmbH

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)