careSTART™ G6PD Biosensor Control Level I - Indonesia BPOM Medical Device Registration
careSTART™ G6PD Biosensor Control Level I is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208123281. 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
Jun 10, 2021
Expiry Date
Feb 19, 2025
Product Type
Hematological Reagents
Hematology quality control mixture.
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