GENEDRIVE HCV ID Kit - Indonesia BPOM Medical Device Registration
GENEDRIVE HCV ID Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305022861. The device is manufactured by GENEDRIVE DIAGNOSTICS LTD. from United Kingdom, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. SYSMEX 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
GENEDRIVE DIAGNOSTICS LTD.Country of Origin
United Kingdom
Authorized Representative
PT. SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Sep 16, 2021
Expiry Date
Oct 17, 2024
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
SYSMEX Automated Blood Coagulation Analyzer CN-6000
SYSMEX CORPORATION
XN CAL PF
DASH, INC.
SULFOLYSER
SYSMEX CORPORATION, ONO FACTORY.
POCH-PACK L PPL-200A
SYSMEX CORPORATION, ONO FACTORY.
EIGHTCHECK-3WP-H
DASH, INC.
XN-CHECK L2
DASH, INC.
SYSMEX CELLSHEATH
SYSMEX CORPORATION, ONO FACTORY.
XN-CHECK™ L3
DASH, INC.
SYSMEX CD4% easy count kit
EXBIO PRAHA, A.S.
SYSMEX Ca Cal S
SYSMEX CORPORATION, SEISHIN FACTORY.