# Stoma® 5176.05

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/stoma-r-5176-05>
- Manufacturer: [Storz am Mark GmbH](https://devicerts.com/manufacturers/storz-am-mark-gmbh) (Germany)
- Name in the registry: STOMA® 5176.05
- Device class: Class I (EU MDR / US FDA)
- FDA product code: EHY
- EMDN: Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE
- GMDN: Dental impression tray, reusable (35850)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI \++ESAM0338T · UDI-DI \+ESAM5176051 · registered 2026-10-05 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI \+ESAM5176051 · listed 2020-08-27 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: Randschluss-Abdrucklöffel, UK, L L5 [EUDAMED]; STOMA® [FDA GUDID (AccessGUDID)]
- Generic name: Dental impression tray, reusable [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 5176.05 [EUDAMED, FDA GUDID (AccessGUDID)]; 35850 - Dental impression tray [EUDAMED]; reusable (033) [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: \+ESAM5176051 [EUDAMED]; ESAM5176051 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: \++ESAM0338T [EUDAMED]
- FDA product code: EHY [FDA GUDID (AccessGUDID)]
- EMDN code: Q010503 [EUDAMED]
- GMDN term: Dental impression tray, reusable (35850) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED, FDA GUDID (AccessGUDID)]
- Regulation number: 872.6880 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Stoma® 5176.05, Storz am Mark GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/stoma-r-5176-05 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/stoma-r-5176-05.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/stoma-r-5176-05
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.