Ep : 0.235
TP : 0.255
CL 0.195
Operación cerrada: objetivo alcanzado
Ep : 0.235
TP : 0.255
CL 0.195
Leveraging on the Company’s expertise in Design & Development (“D&D”) and deep manufacturing experience, it had placed order with a reputable US based 3D printing technology developer and manufacturer to supply 3D printer for the purpose of 3D printing the Nasal Swabs. The US based 3D technology developer and manufacturer, working in collaboration with US healthcare providers have received FDA Class 1 Exempt status for their Nasal Swabs design. The former is currently supplying to these healthcare providers.
The Company shall commence pilot manufacturing of the specific Nasal Swab design by 3D printing using the equipment supplied by the US based 3D printing technology developer and manufacturer by May 2020 in its FDA registered; ISO 13485 facility. As Nasal Swab is considered a medical device, it will be subjected to getting the necessary approvals from the relevant authorities of the subject country (while for US, the subject Nasal Swab has already received FDA Class 1 Exempt status) and for Malaysia, it would include amongst others, approval from the Medical Device Authority (MDA) under the Ministry of Health, Malaysia.