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KUALA LUMPUR: Mah Sing Group Bhd’s healthcare business unit, Mah Sing Healthcare Sdn Bhd, has obtained the Certificate of European Union (EU) Medical Device Regulation (MDR) notification to market its nitrile examination gloves to the EU and European Economic Area (EEA) market.
In a filing to Bursa Malaysia, the company said Mah Sing Healthcare’s MDR classification falls under the Class I-Devices that require completion of a technical file and self-declaration of the conformity of the products.
The product that was stipulated in the clearances is nitrile examination powder-free gloves (non-sterile), it said.
"With the recent issuance of FDA 510K, Health Canada Medical Device Licence, and now the MDR certificate, Mah Sing Healthcare is ready to accelerate the export of medical grade gloves to the United States, Canada, EU, and EEA territories,” it said.
Mah Sing said it has completed the commissioning of all 12 production lines and has already received numerous customer sales enquiries.
These new high-speed glove dipping machines can produce 38,000 pieces of gloves per production line per hour, enabling a maximum production capacity of up to 3.68 billion pieces of gloves per annum, it added. - Bernama