Data / Medical devices / France / Nissha Medical Technologies SAS
Nissha Medical Technologies SAS: FDA-registered device maker in Cergy Val-d'Oise, France, 3 510(k) clearances
Nissha Medical Technologies SAS is registered with the FDA (registration 3004762958) in Cergy Val-d'Oise, France. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004762958
- Address
- 23-25 Boulevard de la Paix, Cergy Val-d'Oise, France, 95800
- Owner or operator
- NISSHA MEDICAL TECHNOLOGIES SAS (10032984)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- July 8, 2010
- Registered through
- 2026
- Brand names listed
- 50400-US IP-SET®P3, 50401-US IP-SET®N3, 50500-US IP-SET®M3, 50501-US IP-SET®M5, 50502-US IP-SET®12, 50503-US IP-SET®6V, 50504-US IP-SET®5V, 50505-US IP-SET®M12 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Burst Suppression Detection Software For Electroencephalograph | ORT | 2 | Contract manufacturer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 2 | Contract manufacturer | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Contract manufacturer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Contract manufacturer | accessdata.fda.gov |
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 29, 2021 | K203350 | ENDOtube | OCX | Substantially Equivalent | Nissha Medical Technologies Sas | accessdata.fda.gov |
| August 16, 2017 | K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables | DSA | Substantially Equivalent | Integral Process Sas | accessdata.fda.gov |
| July 1, 2010 | K101685 | IP-SET | DRX | Substantially Equivalent | Integral Process Sas | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Electrocardiograph
- All makers of Endoscopic Irrigation/Suction System
- All makers of Non-Normalizing Quantitative Electroencephalograph Software
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Burst Suppression Detection Software For Electroencephalograph
- All makers of Probe, Radiofrequency Lesion
Updated September 29, 2021. 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.