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Stoma® 5176.05

by Storz am Mark GmbH

Ref 5176.05Model 35850 - Dental impression tray, reusable (033)

Stoma 5176.05 is a dental impression tray (EU MDR Class I; FDA Class I; FDA product code EHY, Tray, Impression, Preformed) made by Storz am Mark GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI ++ESAM0338T) and listed in FDA GUDID since 27 Aug 2020 (UDI-DI +ESAM5176051), 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++ESAM0338T Basic UDI-DI +ESAM5176051UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+ESAM5176051 UDI-DI Date27 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++ESAM0338T registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI +ESAM5176051 listed 27 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +ESAM5176051
  2. Registered EUDAMED ++ESAM0338T

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  • Withdrawn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
Randschluss-Abdrucklöffel, UK, L L5 EUDAMED
Stoma® GUDID
Generic name
Dental impression tray, reusable
Model / Ref / Catalog
5176.05, 35850 - Dental impression tray, reusable (033)
Primary DI / UDI-DI
+ESAM5176051 EUDAMED
ESAM5176051 GUDID
Basic UDI-DI
++ESAM0338T
FDA product code
EHY
EMDN code
Q010503 Impression material trays, single-use
GMDN term
Dental impression tray, reusable
Device class
Class I
Regulation number
872.6880
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
+ESAM5176051
GUDID
ESAM5176051

The registries describe this device under different primary UDI-DIs (EUDAMED lists +ESAM5176051; FDA GUDID lists ESAM5176051), so their flags are not compared.

Related devices

Category: Dental impression tray, reusable

Similar devices in this category

Other devices filed under IMPRESSION MATERIAL TRAYS, SINGLE-USE.

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, all answered No)