# FineTuner 33807

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

- Canonical page: <https://devicerts.com/devices/finetuner-33807>
- Manufacturer: [Med-El Elektromedizinische Geräte Gesellschaft m.b.H.](https://devicerts.com/manufacturers/med-el-elektromedizinische-gerate-gesellschaft-m-b-h) (FDA registration: United States)
- Device class: Class I (EU MDR); Class III (US FDA)
- FDA product code: MCM
- EMDN: Q0399 ENT DEVICES - OTHER
- GMDN: Hearing aid/implant system remote control (57885)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 9008737Ma0101xxX5 · UDI-DI 09008737338077 · registered 2026-09-01 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 09008737338077 · listed 2020-11-03 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA PMA · United States · P000025 · decision 2001-08-20 · decision APPR · status: Active · from GUDID

## Recalls

- Z-2356-2024 · Class II · ongoing · initiated 2024-04-18: A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
- Z-2138-2019 · Class II · terminated · initiated 2018-10-16 · matched through shared submission P000025, may concern other models: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
- Z-2136-2019 · Class II · terminated · initiated 2018-10-16 · matched through shared submission P000025, may concern other models: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
- Z-2137-2019 · Class II · terminated · initiated 2018-10-16 · matched through shared submission P000025, may concern other models: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

## Identity

- Trade name: FineTuner [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Hearing aid/implant system remote control [FDA GUDID (AccessGUDID)]
- Model / reference: 33807 [EUDAMED, FDA GUDID (AccessGUDID)]; Ma0101xx [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 09008737338077 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 9008737Ma0101xxX5 [EUDAMED]
- PMA number: P000025 [FDA GUDID (AccessGUDID)]
- FDA product code: MCM [FDA GUDID (AccessGUDID)]
- EMDN code: Q0399 [EUDAMED]
- GMDN term: Hearing aid/implant system remote control (57885) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class III [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Austria [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- 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)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: FineTuner 33807, Med-El Elektromedizinische Geräte Gesellschaft m.b.H. deviCERTS medical device catalogue. https://devicerts.com/devices/finetuner-33807 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/finetuner-33807.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/finetuner-33807
- 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.