SMART DIAGNOSTIC Dengue NS1 Test Cassette - Indonesia BPOM Medical Device Registration
SMART DIAGNOSTIC Dengue NS1 Test Cassette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220620. The device is manufactured by RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD from Malaysia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PERUSAHAAN PERSEROAN (PERSERO) INDONESIA FARMA.
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
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHDCountry of Origin
Malaysia
Authorized Representative
PT. PERUSAHAAN PERSEROAN (PERSERO) INDONESIA FARMAAR Address
Jl. Tambak No. 2 RT 013 RW 008
Registration Date
Sep 16, 2022
Expiry Date
Sep 15, 2025
Product Type
Serological Reagents
Dengue virus serological reagents
Invitro Diagnostics
SMART Diagnostic DOA 3 Panel (AMP, MOP, THC)
SMART Diagnostic DOA 5 Panel (AMP, BZO, MET, MOP, THC)
SMART Diagnostic DOA 6 Panel (AMP, BZO, COC, MET, MOP, THC)
SMART Diagnostic DOA 7 Panel (AMP, BZO, COC, MET, MOP, THC, MDMA)
SMART Diagnostic Malaria Pf/Pv Cassette
SMART Diagnostic Malaria Pf/Pan Test Cassette
BEX-Nasogastric Catheter Levin
BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.
SMART Diagnostic HCG Test Strip
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD.
SMART Diagnostic DOA 5 Panel (AMP, BZO, MET, MOP, THC)
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD
SMART Diagnostic DOA 7 Panel (AMP, BZO, COC, MET, MOP, THC, MDMA)
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD
SMART Diagnostic DOA 3 Panel (AMP, MOP, THC)
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD
SMART Diagnostic DOA 6 Panel (AMP, BZO, COC, MET, MOP, THC)
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD
BEX B-CAT2 I.V. Cannula W/ Injection
BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.
BEX Three Way Stopcock Blue
BIÇAKCILAR TIBBI CIHAZLAR SANAYI VE TICARET A.S.
SMART Diagnostic Malaria Pf/Pan Test Cassette
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD
SMART Diagnostic Malaria Pf/Pv Cassette
RESZON DIAGNOSTICS INTERNATIONAL SDN. BHD