I-STAT Create Cartridge - Indonesia BPOM Medical Device Registration
I-STAT Create Cartridge is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101110185. The device is manufactured by ABBOTT POINT of CARE INC CANADA LIMITED. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is TRANSMEDIC 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.
I-STAT Crea Cartridge
Risk Classification
Product Class
Kelas : 2
Manufacturer
ABBOTT POINT of CARE INC CANADA LIMITED.Country of Origin
Canada
Authorized Representative
TRANSMEDIC INDONESIAAR Address
Perkantoran Menara Era Unit G-01 JL.Senen Raya No.135-137 RT 00 RW 00, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Senen, Kel. Senen
Registration Date
Feb 20, 2024
Expiry Date
Jul 01, 2027
Product Type
Clinical Chemistry Test System
Creatinine test system(card)
Invitro Diagnostics
SSPC Delivery Catheter
CENTERPOINT SYSTEMS LLC
SANYOU Spinal Rod System (Thoracolumbar) 8
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Fusion Cage Implant
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 5
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 3
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 4
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Fusion Cage Instrument
SHANGHAI SANYOU MEDICAL CO., LTD.
MEICEN Thermoplastic Mask 2
GUANGDONG MEICEN MEDICAL EQUIPMENT CO., LTD.
EPICโข Plus
ST. JUDE MEDICAL BRASIL LTDA
STRYKER Connected OR Hub System
NOVATECH INDUSTRIES

