careSTART™ G6PD Biosensor Strip - Indonesia BPOM Medical Device Registration
careSTART™ G6PD Biosensor Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207122510. The device is manufactured by WELLS BIO, INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NEXT LEVEL MEDICAL.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
WELLS BIO, INC.Country of Origin
Korea
Authorized Representative
PT. NEXT LEVEL MEDICALAR Address
JALAN BUKIT GADING RAYA, KOMPLEK GADING BUKIT INDAH, BLOK TB KAVLING NO. 30 LT.3
Registration Date
May 03, 2021
Expiry Date
Feb 19, 2025
Product Type
Haematology Package and Kit
Erythrocytic glucose-6-phosphate dehydrogenase assay.
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careSTART™ G6PD Biosensor Control Level II
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