CareGENE™ STD-12 Detection Kit - Indonesia BPOM Medical Device Registration
CareGENE™ STD-12 Detection Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320299. The device is manufactured by WELLS BIO, INC. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is MEDISINDO BAHANA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
WELLS BIO, INC.Country of Origin
Korea
Authorized Representative
MEDISINDO BAHANAAR Address
Rukan Graha Cempaka Mas Blok E No.15 Lt.3, Jl. Letjen Suprapto No.1, Jakarta Pusat
Registration Date
Sep 21, 2023
Expiry Date
Jun 22, 2026
Product Type
Tumor Antigen Immunologic Test System
Dna Detection for Human Papillomavirus
Invitro Diagnostics
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