Data / Medical devices / Netherlands / Enraf-Nonius B.V.
Enraf-Nonius B.V.: FDA-registered device maker in ROTTERDAM Zuid-Holland, Netherlands, 7 510(k) clearances
Enraf-Nonius B.V. is registered with the FDA (registration 9612147) in ROTTERDAM Zuid-Holland, Netherlands. It lists 12 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612147
- FEI number
- 3002806913
- Address
- 127, Vareseweg -, ROTTERDAM Zuid-Holland, Netherlands, NL-3047 AT
- Owner or operator
- NEW COMPANY INVESTMENTS B.V. (9046108)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 14, 2012
- Registered through
- 2026
- Brand names listed
- Compact-II, CryoOne, Curapuls 670, Dynatron SmarTRAC, EN-Dynamic Abdominal Trainer, EN-Dynamic Abduction, EN-Dynamic Adduction, EN-Dynamic Back Trainer and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2025 | K251083 | Compact II | IPF | Substantially Equivalent | Enraf-Nonius, B.V. | accessdata.fda.gov |
| June 25, 2025 | K243112 | Curapuls 670 | IMJ | Substantially Equivalent | Enraf-Nonius, B.V. | accessdata.fda.gov |
| October 24, 2023 | K230472 | Sonopuls 190 | IMI | Substantially Equivalent | Enraf-Nonius, B.V. | accessdata.fda.gov |
| May 25, 2023 | K213256 | ThermoTK | PBX | Substantially Equivalent | Zimmer Medizinsysteme GmbH | accessdata.fda.gov |
| August 26, 2016 | K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | IMG | Substantially Equivalent | Accelerated Care Plus (Acp) | accessdata.fda.gov |
| October 16, 2015 | K151640 | ELTRAC 471 | ITH | Substantially Equivalent | Enraf-Nonius, B.V. | accessdata.fda.gov |
| February 24, 2006 | K060395 | CRYO, MODEL V6.0 | GEX | Substantially Equivalent | Zimmer Elektromedizin GmbH | accessdata.fda.gov |
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Updated September 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.