# Nucleus Z277519

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

- Canonical page: <https://devicerts.com/devices/nucleus-z277519>
- Manufacturer: [Cochlear](https://devicerts.com/manufacturers/cochlear) (FDA registration: Australia)
- Device class: Class III (EU MDR / US FDA)
- FDA product code: MCM
- EMDN: J0380 AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
- GMDN: Hearing aid/implant system remote control (57885)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 9321502CR210KS · UDI-DI 09321502022545 · registered 2026-10-09 · status: Active
- **EUDAMED** · CE/MDR · European Union · G70 078611 0158 · issued 2025-09-11 · expires 2028-04-05 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 09321502022545 · listed 2014-09-24 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA PMA · United States · P970051 · decision 1998-06-25 · decision APPR · status: Active · from GUDID

## EU certificates

- G70 078611 0158 · Technical documentation · MDR · notified body TÜV SÜD Product Service GmbH · issued 2025-09-11 · expires 2028-04-05 · status: supplemented

## Recalls

- Z-2155-2015 · Class II · terminated · initiated 2015-06-05: Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
- Z-0003-2012 ·  · terminated · initiated 2011-09-16: Cochlear implant may shut down and cease to function.
- Z-0119-2010 ·  · terminated · initiated 2009-09-30: Cochlear implant device component was mis-labeled.

## Identity

- Trade name: Cochlear® Nucleus® CR210 Remote Control [EUDAMED]; Nucleus [FDA GUDID (AccessGUDID)]
- Generic name: Hearing aid/implant system remote control [FDA GUDID (AccessGUDID)]
- Device name: Nucleus® CR210 Remote Control [EUDAMED]
- Model / Ref / Catalog: Z277519 [EUDAMED, FDA GUDID (AccessGUDID)]; CR210 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 09321502022545 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 9321502CR210KS [EUDAMED]
- PMA number: P970051 [FDA GUDID (AccessGUDID)]
- FDA product code: MCM [FDA GUDID (AccessGUDID)]
- EMDN code: J0380 [EUDAMED]
- GMDN term: Hearing aid/implant system remote control (57885) [FDA GUDID (AccessGUDID)]

## Classification

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

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: 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)]

## Source and citation

- Cite as: Nucleus Z277519, Cochlear. deviCERTS medical device catalogue. https://devicerts.com/devices/nucleus-z277519 (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: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/nucleus-z277519.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/nucleus-z277519
- 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.