BIO-RAD Monolisa HCV Ag-Ab Ultra V2 - Indonesia BPOM Medical Device Registration
BIO-RAD Monolisa HCV Ag-Ab Ultra V2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305420568. The device is manufactured by BIO-RAD (STEENVOORDE) from France, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.
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
BIO-RAD (STEENVOORDE)Country of Origin
France
Authorized Representative
PT. ANDAMAN MEDICAL INDONESIAAR Address
Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
Registration Date
Nov 20, 2024
Expiry Date
Aug 13, 2029
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
NETRODโข Radio Frequency Renal Ablation Catheter
SHANGHAI GOLDEN LEAF MEDTECH CO., LTD.
BONEUNION MEDICAL Upper Limb Plate
BONEUNION (XIAMEN) MEDICAL DEVICE CO., LTD.
INNOLCON Ultrasonic Surgical System
INNOLCON MEDICAL TECHNOLOGY (SUZHOU) CO., LTD. (BUILDING 10)
NETRODโข Radio Frequency Renal Ablation Device
SHANGHAI GOLDEN LEAF MEDTECH CO., LTD.
PERMEADERM Biosynthetic Wound Matrix
TRELLEBORG SEALING SOLUTIONS US, INC.
PERMEADERM Biosynthetic Wound Matrix
TRELLEBORG SEALING SOLUTIONS US, INC.
PHONAK TERRA+ BTE-M
SONOVA AT
PHONAK TERRA BTE-M
SONOVA AT
PHONAK TERRA+ RIC-312
SONOVA AT
PHONAK TERRA+ BTE-UP
SONOVA AT

