Enraf-Nonius B.V.
ROTTERDAM Zuid-Holland, NL
ENRAF-NONIUS B.V. appears in FDA device records in ROTTERDAM Zuid-Holland, NL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Enraf-Nonius B.V. between 2003 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2015 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251083 | Compact II | IPF | Substantially Equivalent | |
| K243112 | Curapuls 670 | IMJ | Substantially Equivalent | |
| K230472 | Sonopuls 190 | IMI | Substantially Equivalent | |
| K151640 | ELTRAC 471 | ITH | Substantially Equivalent | |
| K030297 | FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 | GXY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9612147 | 3002806913 | ENRAF-NONIUS B.V. | 127, VARESEWEG, ROTTERDAM Zuid-Holland NL-3047 AT NL | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- ITHEquipment, Traction, Powered
- BXBExerciser, Powered
- ILYLamp, Infrared, Therapeutic Heating
- ISAMassager, Therapeutic, Electric
- PBXMassager, Vacuum, Radio Frequency Induced Heat
- GEXPowered Laser Surgical Instrument
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- INQTable, Powered
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain