FDA Registration
Active
🇫🇷 France
NISSHA MEDICAL TECHNOLOGIES SAS
Reg #: 3004762958
·
FEI: 3004762958
·
Expires 2026
Products
7
Proprietary Names
42
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- NISSHA MEDICAL TECHNOLOGIES SAS
- Registration Number
- 3004762958
- FEI Number
- 3004762958
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 23-25 Boulevard de la Paix
- City
- Cergy Val-d'Oise
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K162768
Owner / Operator
- Firm Name
- NISSHA MEDICAL TECHNOLOGIES SAS
- Operator Number
- 10032984
- Address
- 400 Exchange Street
- City
- Buffalo
- State
- NY
- Postal Code
- 14204
- Country
- US
- Correspondent
- Jessica Potter
US Agent
- Business Name
- NISSHA MEDICAL TECHNOLOGIES
- Contact Name
- Jessica POTTER
- Address
- Graphic Controls d.b.a. Vermed, 400 Exchange Street
- City
- Buffalo
- State
- NY
- ZIP
- 14204
- Country
- US
- [email protected]
- Phone
- 716 8537500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2017-11-28 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2021-02-02 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2022-06-14 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2010-07-13 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2010-07-08 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2010-07-08 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2010-07-08 |
Proprietary Names
INTEGRAL PROCESS PATIENT CABLES
50601-US IP-SET®M5RT
50604-US IP-SET®5VRT
50507-US IP-SET®C
50603-US IP-SET®6VRT
50505-US IP-SET®M12
50504-US IP-SET®5V
50503-US IP-SET®6V
50602-US IP-SET®12RT
50401-US IP-SET®N3
50506-US IP-SET®12S
50500-US IP-SET®M3
50501-US IP-SET®M5
50600-US IP-SET®M3RT
50605-US IP-SET®M12RT
50400-US IP-SET®P3
50502-US IP-SET®12
898040-EEG lead red clip bipolar
898045-EEG lead yellow cup bipolar
898146-EEG lead yellow cup refer.
898149-EEG lead green cup refer.
898155 - Customized EEG lead kit 8
898150-EEG lead empty block
898039-EEG lead black (ground) cup
898038-EEG lead black (ground) clip
898041-EEG lead red cup bipolar
898145-EEG lead yellow clip refer.
898050-EEG lead set 1, 2 ch bipolar
898154 - Customized EEG lead kit 7
898153 - Customized EEG lead kit 6
898151 - Customized EEG lead kit 4
898052-EEG lead set 3, 2 ch refer.
898143-EEG lead blue cup refer.
898043-EEG lead blue cup bipolar
898144-EEG lead yellow clip bipolar
898044-EEG lead blue clip refer.
898046-EEG lead green cup bipolar
898147-EEG lead green clip bipolar
898152 - Customized EEG lead kit 5
898042-EEG lead blue clip bipolar
898148-EEG lead green clip refer.
898051-EEG lead set 2, 4 ch bipolar
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198