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ONETEXX SDN.BHD.

Malaysia·MY-MF-000024836

Last updated June 8, 2026

Information

Country
Malaysia
Address
Perindustrian Kamunting 3, Lot 73-86, Jalan Logam 5, , Kamunting, Malaysia
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Sharan Jit
EUDAMED SRN
MY-MF-000024836
FDA FEI Number
—
DUNS Number
—

Catalogue (16)

DeviceModel / ReferenceRegistriesClassStatus
POPPY Powder-Free Nitrile Examination Gloves N030SKB-M
EUDAMED
Class IActive
POPPY Powder-Free Nitrile Examination Gloves N030MBK-M
EUDAMED
Class IActive
White Nitrile Powder Free Patient Examination Glove, Non Sterile K210775
FDA 510(k)
Class IActive
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile K210587
FDA 510(k)
Class IActive
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid K222294
FDA 510(k)
Class IActive
Black Nitrile Powder Free Patient Examination Glove, Non Sterile K210588
FDA 510(k)
Class IActive
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid K222298
FDA 510(k)
Class IActive
Österreichische Roten Kreuz (2023094 – M) (N035MNV)
EUDAMED
Class IActive
Quantus Medical Nitril (QM5218101YNB-S)(N035MNV)
EUDAMED
Class IActive
Österreichische Roten Kreuz (2023093 – S) (N035MNV)
EUDAMED
Class IActive
Quantus Medical Nitril (QM5218101YNB-XL) (N035MNV)
EUDAMED
Class IActive
POPPY Powder-Free Nitrile Examination Glove N030MBK-L
EUDAMED
Class IActive
Quantus Medical Nitril (QM5218101YNB-M) (N035MNV)
EUDAMED
Class IActive
Österreichische Roten Kreuz (2023095 – L) (N035MNV)
EUDAMED
Class IActive
Österreichische Roten Kreuz (2023096 – XL) (N035MNV)
EUDAMED
Class IActive
Quantus Medical Nitril (QM5218101YNB-L) (N035MNV)
EUDAMED
Class IActive

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