Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004762958

FEI Number

3004762958

Entity Name

NISSHA MEDICAL TECHNOLOGIES SAS

City/State/Country

Cergy Val-d'Oise, FR

Establishment Address

23-25 Boulevard de la Paix, Cergy Val-d'Oise 95800, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NISSHA MEDICAL TECHNOLOGIES SAS (Owner Number: 10032984)

Owner / Operator Contact Address

400 Exchange Street, Buffalo, NY 14204, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-11-28
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2021-02-02
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2022-06-14
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2010-07-13
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2010-07-08
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2010-07-08
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2010-07-08

Official Correspondent

Jessica Potter

US Agent Details

Jessica POTTER Business: NISSHA MEDICAL TECHNOLOGIES Email: jpotter@nisshamedical.com Phone: (716) 8537500

Related Public Records

Same Entity

NISSHA MEDICAL TECHNOLOGIES SAS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880323	Medtronic Vascular	MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR	1988-03-22
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Similar Registrations

Registration Number	Establishment Name	Location
3017528618	ATRILITY MEDICAL, INC.	Madison, WI, US
3017619000	SHENZHEN REDY-MED TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
2939520	VOLCANO CORPORATION	Rancho Cordova, CA, US
3017636737	STERIS Corporation de Republica Dominicana, S.R.L.	Santo Domingo, DO
3004859241	BOSTON SCIENTIFIC CORPORATION	La Aurora Heredia, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004762958. Last updated year: 2026. Please use registration number 3004762958 when referencing this establishment in official correspondence.