RAMP Myoglobin Assay - Indonesia BPOM Medical Device Registration
RAMP Myoglobin Assay is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305213438. The device is manufactured by RESPONSE BIOMEDICAL CORPORATION. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FAITHFUL MEDICAL GRACE.
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
RESPONSE BIOMEDICAL CORPORATION.Country of Origin
Canada
Authorized Representative
FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Mar 30, 2022
Expiry Date
Jan 21, 2027
Product Type
Immunological Test System
Myoglobin immunological test system.
Invitro Diagnostics
RAMP Reader System and Accessories
RAMP Cardiac Controls Level 2
RAMP Procalcitonin Controls Level 1
RAMP 200 System and Accessories
RAMP Procalcitonin Controls Level 2
RAMP NT-proBNP Assay
RESPONSE RAMP D-dimer
RAMP CK-MB Assay
Cornley Electrolytes Quality Control (Low Level)
MEIZHOU CORNLEY HI-TECH , CO., LTD.
Cornley TCO2 Quality Control
MEIZHOU CORNLEY HI-TECH , CO., LTD.
CORNLEY K-LITE 8G Electrolyte Analyzer and Accessories
MEIZHOU CORNLEY HI-TECH , CO., LTD.
ZHUHAI Anaerobic Blood Culture Bottle
ZHUHAI DL BIOTECH CO., LTD.
ZHUHAI DL-96 STAPH IST Card
ZHUHAI DL BIOTECH CO., LTD.
ZHUHAI DL-96 STREP IST card
ZHUHAI DL BIOTECH CO., LTD
LEPU Nucleic Acid Extraction or Purification Kit
BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD
Drawray Sample Diluent A-1
SHENZHEN YHLO BIOTECH CO., LTD
CORNLEY K-LITE 8B Electrolyte Analyzer and Accessories
MEIZHOU CORNLEY HI-TECH , CO., LTD.
Drawere Lining-Hag
HUNAN DRAWRAY BIOTECH CO., LTD