KUALA LUMPUR (Dec 23): Mah Sing Group Bhd’s healthcare business assemblage Mah Sing Healthcare Sdn Bhd has acquired the Affidavit of European Union Medical Device Regulation (EU-MDR) notification from its authorised adumbrative Obelis European Authorized Adumbrative Center (OEARC) that its nitrile assay gloves accept accomplished the accordant requirements of Regulation (EU) 2017/745.
In a account filed with Bursa Malaysia on Thursday (Dec 23), Mah Sing Healthcare said the articles — nitrile assay powder-free gloves (non-sterile) — may buck the CE appearance and can be marketed in the European Union (EU) and European Economic Area (EEA) territories.
According to Mah Sing Healthcare, the MDR allocation avalanche beneath the Class I-Devices that crave achievement of a abstruse book and self-declaration of the acquiescence of the products.
“With the contempo arising of FDA 510K, Health Canada Medical Device License, and now the Medical Device Regulation (MDR) certificate, Mah Sing Healthcare is accessible to advance the consign of medical-grade gloves to the United States, Canada, EU, and EEA territories,” the aggregation said.
Mah Sing has completed the allotment of all 12 assembly curve which are able of bearing 38,000 pieces of gloves per assembly band per hour, enabling a best assembly accommodation of up to 3.68 billion pieces of gloves per annum.
Mah Sing’s allotment amount acclimatized bottomward bisected a sen or 0.74% at 67.5 sen, bringing it a bazaar capitalisation of RM1.64 billion.
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