careUS ™ Flu A&B Plus - Indonesia BPOM Medical Device Registration
careUS ™ Flu A&B Plus is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420350. The device is manufactured by WELLS BIO, INC. from Korea, Democratic People's Republic Of, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is MEDISINDO BAHANA.
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.
careUS ™ Flu A&B Plus
Risk Classification
Product Class
Kelas : 2
Manufacturer
WELLS BIO, INC.Country of Origin
Korea, Democratic People's Republic Of
Authorized Representative
MEDISINDO BAHANAAR Address
GRAHA CEMPAKA MAS BLOK D No. 9 & Blok E NO.15 JL. LETJEN SUPRAPTO SUMUR BATU
Registration Date
Aug 07, 2024
Expiry Date
Mar 01, 2029
Product Type
Serological Reagents
Influenza virus serological reagents.
Invitro Diagnostics
CARESTART™ Malaria HRP2/pLDH (Pf/PAN) Combo
CareGENE™ STD-12 Detection Kit
careGENE™ HPV Detection kit-M
careGENE™ HPV Screening kit-H
careUS™ Malaria Combo Pf/PAN (HRP2/pLDH) Ag
careUS™ Malaria Combo Pf/PAN (HRP2/pLDH) Ag
careSTART™ G6PD Biosensor Control Level I
careSTART™ G6PD Biosensor Control Level II
careSTART™ G6PD Biosensor Analyzer
careSTART™ G6PD Biosensor Strip
ROSSMAX Peak Flow Meter PF120C
SHANGHAI EVERPURE MEDICAL PLASTIC CO., LTD.
ROSSMAX Peak Flow Meter PF120A
SHANGHAI EVERPURE MEDICAL PLASTIC CO., LTD.
ROSSMAX Digital Thermometer TG100
JOYTECH HEALTHCARE CO. LTD.
CareStart™ Dengue NS1
ACCESS BIO KOREA, INC.
CareStart™ Dengue Combo NS1 & IgM/IgG
ACCESS BIO KOREA, INC.
CareGENE™ STD-12 Detection Kit
WELLS BIO, INC.
P4Detect Dengue IgM/IgG
PRIME4DIA CO.,LTD
familyDr. Uni Uric Acid Monitoring Meter
GENERAL LIFE BIOTECHNOLOGY
SO 10M
DFI CO., LTD.
ROSSMAX Qutie Electronic Baby Scale
GUANGDONG WINBURG TECHNOLOGY CO., LTD.