# Complete Control System Gen2

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

- Canonical page: <https://devicerts.com/devices/complete-control-system-gen2-n1>
- Manufacturer: [Coapt, LLC](https://devicerts.com/manufacturers/coapt-llc) (United States)
- Device class: Class I (EU MDR); Class II (US FDA)
- FDA product code: GXY
- EMDN: Y061899 UPPER EXTREMITY PROSTHESES - OTHER
- EMDN: Z12100492 ELECTROMYOGRAPHY INSTRUMENTS -MEDICAL DEVICE SOFTWARE
- GMDN: Myoelectric hand prosthesis (41497)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI \++B618N18Z · UDI-DI B618N1 · registered 2021-11-10 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI B618N1 · listed 2019-06-12 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K191083 · issued 2019-05-24 · status: Active
- **510(k)** · FDA 510(k) · United States · K162891 · issued 2017-04-14 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Myoelectric hand prosthesis [FDA GUDID (AccessGUDID)]
- Model / reference: N1 [EUDAMED]; 1 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: B618N1 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: \++B618N18Z [EUDAMED]
- 510(k) Number: K191083 [FDA GUDID (AccessGUDID)]
- FDA product code: GXY [FDA GUDID (AccessGUDID)]
- EMDN code: Y061899 [EUDAMED]; Z12100492 [EUDAMED]
- GMDN term: Myoelectric hand prosthesis (41497) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.1320 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Sweden [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: Complete Control System Gen2, Coapt, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/complete-control-system-gen2-n1 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/complete-control-system-gen2-n1.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/complete-control-system-gen2-n1
- 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.