# Enraf-Nonius, B.V.

- Location (FDA's records): Rotterdam, NL
- FDA decisions: 5 (2003–2025): 5 510(k) clearances
- Product codes: GXY (1), IPF (1), IMI (1), ITH (1), IMJ (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Henley Intl.: 1 (https://510kreport.com/company/henley-intl)
- Remed Co., Ltd.: 1 (https://510kreport.com/company/remed)
- Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto: 1 (https://510kreport.com/company/carci-industria-e-comercio-de-aparelhos-cirurgicos-e-orto)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- BTL Industries, Inc.: 1 (https://510kreport.com/company/btl-industries)

## Firms that cite its devices most
- Zimmer Medizinsysteme GmbH: 1 (https://510kreport.com/company/zimmer-medizinsysteme)
- Hironic Co., Ltd.: 1 (https://510kreport.com/company/hironic)

## Its most-cited devices
- K230472: Sonopuls 190 (2023), cited by 1
- K151640: Eltrac 471 (2015), cited by 1

## Recent decisions
- K251083: Compact II (Sep 12, 2025)
- K243112: Curapuls 670 (Jun 25, 2025)
- K230472: Sonopuls 190 (Oct 24, 2023)
- K151640: Eltrac 471 (Oct 16, 2015)
- K030297: Flexible Rubber Electrodes, Models: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 (Apr 28, 2003)

Source page: https://510kreport.com/company/enraf-nonius