careSTART™ G6PD Biosensor Control Level II - Indonesia BPOM Medical Device Registration
careSTART™ G6PD Biosensor Control Level II is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208123313. The device is manufactured by WELLS BIO, INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NEXT LEVEL MEDICAL.
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
WELLS BIO, INC.Country of Origin
Korea
Authorized Representative
PT. NEXT LEVEL MEDICALAR Address
JALAN BUKIT GADING RAYA, KOMPLEK GADING BUKIT INDAH, BLOK TB KAVLING NO. 30 LT.3
Registration Date
Jun 10, 2021
Expiry Date
Feb 19, 2025
Product Type
Hematological Reagents
Hematology quality control mixture.
Invitro Diagnostics
CARESTART™ Malaria HRP2/pLDH (Pf/PAN) Combo
careUS ™ Flu A&B Plus
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 Analyzer
careSTART™ G6PD Biosensor Strip
XPER Technology I1 Multi-Functional Monitoring System
TAIDOC TECHNOLOGY CORPORATION
GREENCARE PRIME Blood Glucose Test Strip
GC MEDICAL SCIENCE CORPORATION
GREENCARE Hb Plus Hemoglobin Test Strip
GC MEDICAL CORP.
GREENCARE Hb Plus Hemoglobin Test Meter
GC MEDICAL CORP.
XPER Technology Procheck Advance β-Ketone Test Strips
TAIDOC TECHNOLOGY CORPORATION
ALCOSCAN AL1100
SENTECH KOREA, CORP.
ALCOSCAN
SENTECH KOREA, CORP.
ALCOSCAN EBS-010
SENTECH KOREA CORP.
XPER Technology Procheck Advance Multi-Functional Monitoring System
TAIDOC TECHNOLOGY CORPORATION
XPER Technology Procheck Advance Total Cholesterol Test Strips
TAIDOC TECHNOLOGY CORPORATION