OVUTEST Digital - Indonesia BPOM Medical Device Registration
OVUTEST Digital is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323020. The device is manufactured by SUGENTECH,INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DANPAC PHARMA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
SUGENTECH,INC.Country of Origin
Korea
Authorized Representative
PT. DANPAC PHARMAAR Address
Plaza Asia, Lt. 6D, Kav. 59, RT 005/RW 003
Registration Date
Jun 07, 2023
Expiry Date
Mar 03, 2026
Product Type
Clinical Chemistry Test System
Luteinizing hormone test system (strip & midstream)
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