ALINITY i PIVKA-II Calibrators - Indonesia BPOM Medical Device Registration
ALINITY i PIVKA-II Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208913137. 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 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
ABBOTT PRODUCTS INDONESIAAR Address
WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA
Registration Date
Oct 20, 2022
Expiry Date
Mar 21, 2027
Product Type
Hematological Reagents
Calibrator for red cell and white cell counting.
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
ARCHITECT Estradiol Reagent Kit
ABBOTT IRELAND DIAGNOSTICS DIVISION.
ARMADA 35 PTA Catheter
ABBOTT VASCULAR COSTA RICA
ARCHITECT PIVKA-II Controls
DENKA CO., LTD.
ARCHITECT PIVKA-II Reagent Kit
DENKA CO., LTD.
ALINITY i PIVKA-II Controls
DENKA CO., LTD.
ALINITY i PIVKA-II Calibrators
DENKA CO., LTD.
XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System
ABBOTT VASCULAR
ALINITY c Calcium2
ABBOTT IRELAND DIAGNOSTICS DIVISION
HI-TORQUE Command 18 LT Guide Wire
ABBOTT VASCULAR
ARCHITECT BNP Controls
FUJIREBIO DIAGNOSTICS, INC.