Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008933393

FEI Number

3008933393

Entity Name

Nissha Medical Technologies Limited

City/State/Country

Paignton Devon, GB

Establishment Address

Torbay Business Park, Woodview Road, Paignton Devon TQ4 7HP, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Nissha Medical Technologies (Owner Number: 9106359)

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

Nissha Medical Technologies Neutral Electrodes - Swaroplate Nissha Medical Technologies Neutral Electrodes - Boston Scientific Nissha Medical Technologies Neutral Electrodes - Stryker Swaromed Z-Brand SofTouch SilveRest VersaTrode Lead-Lok BluFlex V-Series EMS Electrodes TenderTrode Plus PhysioFlow PNS Electrodes ClearScan Guardian Performance Plus TenderTrode Regal SimplySnap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-03-09
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2012-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Jessica Potter Business: GRAPHIC CONTROLS d.b.a Nissha Medical Technologies Email: jpotter@nisshamedical.com Phone: (716) 8496367

Related Public Records

Same Entity

Nissha Medical Technologies

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1317188	Graphic Controls Acquisition Corp.dba Nissha Medical Technologies	BUFFALO, NY, US
3006891611	CEA Global Dominicana d.b.a. Nissha Medical Technologies	San Pedro de Macoris, DO
3023164	LEAD-LOK, INC. d.b.a Nissha Medical Technologies	Sandpoint, ID, US
1721983	CEA Medical Manufacturing, Inc.	Colorado Springs, CO, US
1519132	Nissha Medical Technologies (Ohio), Inc.	Norwalk, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008933393. Last updated year: 2026. Please use registration number 3008933393 when referencing this establishment in official correspondence.