NycoCard ™ Reader II and Accessories - Indonesia BPOM Medical Device Registration
NycoCard ™ Reader II and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102027694. The device is manufactured by ABBOTT DIAGNOSTICS TECHNOLOGIES AS from Norway, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ALERE HEALTH.
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
ABBOTT DIAGNOSTICS TECHNOLOGIES ASCountry of Origin
Norway
Authorized Representative
PT. ALERE HEALTHAR Address
K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan
Registration Date
Dec 11, 2020
Expiry Date
Jul 06, 2025
Product Type
Clinical Laboratory Equipment
Instrumentation for clinical multiplex test systems.
Invitro Diagnostics
AFINION™ Lipid Panel Control
AFINION™ Lipid Panel
AFINION™ ACR
AFINION ™ ACR Control
AFINION™ HbA1c
AFINION™ 2 and Accessories
Afinion™ HbA1c Control
NYCOCARD™ CRP
AFINION™ CRP
NYCOCARD ™ HbA1c Control
DETERMINE HBsAg 2
ABBOTT DIAGNOSTICS MEDICAL CO., LTD.
Bioline™ HCV
ABBOTT DIAGNOSTICS KOREA INC
BIOLINE Salmonella Typhi IgG/IgM Fast
ABBOTT DIAGNOSTICS KOREA INC
AFINION™ Lipid Panel Control
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
DETERMINE™ HIV Early Detect
ABBOTT DIAGNOSTICS MEDICAL CO., LTD
BIOLINE™ Dengue NS1 Ag
ABBOTT DIAGNOSTICS KOREA INC
BIOLINE™ Rotavirus
ABBOTT DIAGNOSTICS KOREA INC
AFINION™ Lipid Panel
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
BIOLINE™ Dengue Duo
ABBOTT DIAGNOSTICS KOREA INC
ALERE NT-proBNP for Alinity i Controls
AXIS-SHIELD DIAGNOSTICS, LTD.

