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OTHERS Notion VTec Berhad ("NVB" or "the Company") - New Business Activities in the Healthcare Industry
NOTION VTEC BERHAD |
Type | Announcement | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject | OTHERS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Description | Notion VTec Berhad ("NVB" or "the Company") - New Business Activities in the Healthcare Industry | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
We refer to the Company's announcement dated 30 October 2020 in relation to New Business Activities in the Healthcare Industry.
The Board of Directors (“Board”) wishes to announce that Notion Venture Sdn Bhd ("NVSB"), a wholly owned subsidiary of the Company, has obtained a Certificate of Registration from Registrar Corp certified that NVSB is registered with the U.S. Food and Drug Administration (“FDA”) for Financial Year 2021 for the Polymer Patient Examination Glove. Please note that the Company needs a 510(k), a premarket submission to FDA demonstrates that the device to be marketed is safe and effective and the submission is currently underway.
Also, the Company has submitted the necessary documents to apply for the European Conformity (CE) marking certification for the nitrile gloves from the European Union and the approval is expected to be obtained soon.
Both certifications are necessary for marketing the nitrile gloves in the USA and Europe, in which the Company’s nitrile gloves is currently supplied by Original Equipment Manufacturers, and brand building of the “Novid” brand will be taking place before the Company’s gloves production starts in middle of 2021.
Furthermore, the Company is also engaging with potential glove buyers on Manufacturing Lease Agreement on some gloves lines to be set up. NVB will dedicate all the output of the lines to glove buyers on a Cost Plus basis with an upfront leasing charge over a period of 24 months. By doing so, it is able to mitigate risks of NVB.
The Company will make further announcements whenever there is any material development on the above business activities.
This announcement is dated 2 November 2020.
Changes in Director's Interest (Section 219 of CA 2016)
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