ARCHITECT Insulin Reagent - Indonesia BPOM Medical Device Registration
ARCHITECT Insulin Reagent is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101914156. The device is manufactured by DENKA SEIKEN CO., LTD. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS 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
DENKA SEIKEN CO., LTD.Country of Origin
Japan
Authorized Representative
PT. ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Jul 29, 2019
Expiry Date
May 30, 2024
Product Type
Clinical Chemistry Test System
Immunoreactive insulin test system (kit & cair)
Invitro Diagnostics
ARCHITECT PIVKA-II Calibrators
ARCHITECT PIVKA II-Reagent Kit
ARCHITECT PIVKA-II Controls
ARCHITECT Insulin Calibrators
ARCHITECT SCC Calibrators
ARCHITECT iPhenobarbital Reagent Kit
ABX Pentra Low CRP Control
ALINITY i ProGRP Reagent Kit
ALINITY i SCC Calibrators
ALINITY i ProGRP Calibrators
ALINITY c Lactate Dehydrogenase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Total T4 Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ALINITY c Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION
ARCHITECT Consolidated Chemistry Calibrator
RANDOX LABORATORIES, LTD
ARCHITECT Total T4 Controls
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 NTW Clip Delivery System
ABBOTT MEDICAL (MENLO PARK)
ABBOTT Amylase2
ABBOTT IRELAND DIAGNOSTICS DIVISION.
MITRACLIP G4 Steerable Guide Catheter
ABBOTT MEDICAL. (Menlo park)
CELL-DYN Emerald 22 Diluent
AVANTOR PERFORMANCE MATERIALS S.A.
ALINITY hs Slide Maker Stainer Module and Accessories
SANMINA-SCI SYSTEMS SINGAPORE PTE LTD

