# FREND System

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

- Canonical page: <https://devicerts.com/devices/frend-system-f10>
- Manufacturer: [NanoEntek, Inc.](https://devicerts.com/manufacturers/nanoentek-inc) (South Korea)
- Device class: Class A (EU IVDR); Class I (US FDA)
- FDA product code: KHO, LTJ
- EMDN: W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput \<= 100 test/h)
- GMDN: Fluorescent immunoassay analyser IVD, point-of-care (48014)

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 880931754FRENDKQ · UDI-DI 08809317540207 · registered 2024-02-28 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08809317540207 · listed 2018-05-04 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K124056 · decision 2013-05-29 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Generic name: Fluorescent immunoassay analyser IVD, point-of-care [FDA GUDID (AccessGUDID)]
- Model / reference: FREND System [EUDAMED]; F10 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08809317540207 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 880931754FRENDKQ [EUDAMED]
- 510(k) Number: K124056 [FDA GUDID (AccessGUDID)]
- FDA product code: KHO [FDA GUDID (AccessGUDID)]
- EMDN code: W0201020101 [EUDAMED]
- GMDN term: Fluorescent immunoassay analyser IVD, point-of-care (48014) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class A [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 862.2560 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Czechia [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Professional testing: Yes [EUDAMED]
- IVD instrument: Yes [EUDAMED]
- 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 [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Reagent: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- New device: 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: FREND System, NanoEntek, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/frend-system-f10 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/frend-system-f10.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/frend-system-f10
- 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.