ESIGHT One Step Test Device Diagnostic Kit for Detection of Hepatitis B Surface Antigen Test, Strip - Indonesia BPOM Medical Device Registration
ESIGHT One Step Test Device Diagnostic Kit for Detection of Hepatitis B Surface Antigen Test, Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305320933. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. SARANA KARYA MEDIKA.
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 : 3
Manufacturer
NANTONG EGENS BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. SARANA KARYA MEDIKAAR Address
UBUD VILLAGE BLOK KINTAMANI C1 NO.15 KEL.SUDIMARA TIMUR
Registration Date
Jun 25, 2023
Expiry Date
Feb 01, 2027
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
QUALITY ACCESS Syphilis (Treponema Pallidum Antibody) Test Strip (Whole Blood/Serum/Plasma)
QUALITY ACCESS Syphilis (Treponema Pallidum Antibody) Test Cassette (Whole Blood/Serum/Plasma)
Quality Accessยฎ HCG Test Cassette (Urine)
Quality Accessยฎ HCG Test Strip (Urine)
QUALITY ACCESS HBsAg Test Cassette (WB/Serum/Plasma)
StandaReagen Combo Diagnostic Kit Multi Drug Panel 7 in 1 (AMP/MOP/THC/MET/COC/BZO/SOMA)
EGENS HCG Pregnancy Test
EGENS HCG Pregnancy Test
EGENS One Step Test Device Diagnostic Kit for Amphetamine (Cassette)
EGENS One Step Test Device Dengue NS1 Antigen Serum/Plasma Test, Cassette
EGENS Diagnostic Kit for Tuberculosis Antibody Test, Cassette
NANTONG EGENS BIOTECHNOLOGY CO., LTD, CHINA
NEW STANDAR REAGEN Diagnostic Kit for Tuberculosis Antibody Test, Cassette
NANTONG EGENS BIOTECHNOLOGY CO., LTD, CHINA
New Standar Reagen Diagnostic Kit for Antibody to Hepatitis C virus, Strip
NANTONG EGENS BIOTECHNOLOGY CO., LTD., CHINA
New Standar Reagen HCG Pregnancy Test, Cassette
NANTONG EGENS BIOTECHNOLOGY CO., LTD., CHINA
New Standar Reagen HCG Pregnancy Test, Strip
NANTONG EGENS BIOTECHNOLOGY CO., LTD, CHINA
NEW STANDAR REAGEN Diagnostic Kit for Antibody to Treponema Pallidum, Cassette
NANTONG EGENS BIOTECHNOLOGY CO., LTD, CHINA
NEW STANDAR REAGEN Diagnostic Kit for Treponema Pallidum, Strip
NANTONG EGENS BIOTECHNOLOGY CO., LTD, CHINA
NEW STANDAR REAGEN Dengue IgM/IgG test, Cassette
NANTONG EGENS BIOTECHNOLOGY CO., LTD, CHINA
NEW STANDAR REAGEN Dengue NS1 Antigen Test, Cassette
NANTONG EGENS BIOTECHNOLOGY CO., LTD., CHINA
NEW STANDAR REAGEN Combo Diagnostic Kit, Multi Drug Panel 6 in 1 (AMP 1.000/MOP 300/THC 50/MET 1.000/COC 300/BZO 300)
NANTONG EGENS BIOTECHNOLOGY CO., LTD., CHINA

