MEDITAPE CHECK 2 - Indonesia BPOM Medical Device Registration
MEDITAPE CHECK 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101813528. The device is manufactured by SYSMEX INTERNATIONAL REAGENTS,CO.,LTD. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is 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 : 2
Manufacturer
SYSMEX INTERNATIONAL REAGENTS,CO.,LTD.Country of Origin
Japan
Authorized Representative
SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Jul 14, 2021
Expiry Date
Jan 28, 2026
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
HISCL Troponin T hs Assay Kit
SYSMEX CORPORATION, SEISHIN FACTORY.
STROMATOLYSER -FB
SYSMEX CORPORATION, ONO FACTORY.
POCH-PACK D PPD - 300A
SYSMEX CORPORATION, ONO FACTORY.
Eightcheck-3WP-L
DASH, INC.
CELLPACK
SYSMEX CORPORATION, ONO FACTORY.
STROMATOLYSER-4DL
SYSMEX CORPORATION, ONO FACTORY.
HISCL HBeAg Assay Kit
JAPAN LYOPHILIZATION LABORATORY.
SYSMEX CELLPACK โข DFL
SYSMEX ASIA PACIFIC PTE., LTD.
TruLab Urine Level 2
DIASYS DIAGNOSTIC SYSTEMS GMBH
TruLab Urine Level 1
DIASYS DIAGNOSTIC SYSTEMS GMBH

