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Stoma® 13388.06

by Storz am Mark GmbH

Ref 13388.06Model 45329 - Dental soft-tissue coring punch, reusable (050)

Stoma® 13388.06 is a device classified as Class IIa in the EU and Class I in the US made by Storz am Mark GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI ++ESAM0508T) with CE/MDR certificate 1000330398 valid until 11 Apr 2029 and listed in FDA GUDID since 27 Aug 2020 (UDI-DI +ESAM13388061), active as of 23 Oct 2026.

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

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++ESAM0508T Basic UDI-DI +ESAM13388061UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ESAM13388061 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++ESAM0508T registered 5 Oct 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI +ESAM13388061 listed 27 Aug 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 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

Timeline

4 dated events

  1. Listed FDA GUDID +ESAM13388061
  2. Certificate issued EUDAMED 1000330398
  3. Registered EUDAMED ++ESAM0508T
  4. Certificate expires EUDAMED 1000330398

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  • Withdrawn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
Schleimhautstanze, Palti, Ø 6mm EUDAMED
Stoma® GUDID
Generic name
Dental soft-tissue coring punch, reusable
Model / Ref / Catalog
13388.06, 45329 - Dental soft-tissue coring punch, reusable (050)
Primary DI / UDI-DI
+ESAM13388061 EUDAMED
ESAM13388061 GUDID
Basic UDI-DI
++ESAM0508T
FDA product code
EJL
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental soft-tissue coring punch, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3240
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 · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+ESAM13388061
GUDID
ESAM13388061
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists +ESAM13388061; FDA GUDID lists ESAM13388061), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental soft-tissue coring punch, reusable

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

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Properties

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