EU → North America Device Access

Nissha Medical Technologies Ltd

GB-MF-000012057 · United Kingdom · Paignton

Nissha Medical Technologies Ltd is registered in the European database on medical devices as a manufacturer, with 114 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa114

Most frequent device types declared: Corpuls, Dräger, Lead-Lok, Lumed, PhysioFlow.

Authorised representative in the Union: NISSHA MEDICAL TECHNOLOGIES SAS.

Devices declared under this manufacturer

Showing 12 of 114 declared devices.

Catalogue references include 4008D, 4022, 4077, 4114, BLLM55, BLM32.

European nomenclature codes declared: C020501.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNissha Medical Technologies Limited (GB) · FDA 3008933393
Devices in EUDAMED114
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN114
Found in the U.S. device database10
Share8.8 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryNISSHA MEDICAL TECHNOLOGIES SAS

What it holds in Canada

Licences on record5
Currently active0
Class 2 devices5
First licensed2015-08-21

Licence types: Device Family (4), Device Group Family (1).

Licensed under: ECG ADAPTER CABLES, IP-SET ECG ELECTRODES, ECG CABLES, ECG LEADWIRES AND LEADS, CABLE ADAPTERS FOR PRE-GELLED ELECTROSURGICAL .

North American profile: Both markets. Nissha Medical Technologies Ltd is registered in both the United States and Canada.

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