MADSEN Astera - Indonesia BPOM Medical Device Registration
MADSEN Astera is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20701420025. The device is manufactured by NATUS MANUFACTURING LIMITED from Ireland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. CEKINDO BUSINESS INTERNATIONAL.
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
NATUS MANUFACTURING LIMITEDCountry of Origin
Ireland
Authorized Representative
PT. CEKINDO BUSINESS INTERNATIONALAR Address
CEKINDO BUSINESS INTERNATIONAL
Registration Date
May 08, 2024
Expiry Date
Apr 01, 2027
Product Type
Diagnostic Ear, Nose and Throat Equipment
Audiometer.
Non Radiation Electromedics
ICS Impulse
MADSEN Zodiac SA Diagnostic Clinical
MADSEN Zodiac SA Quick Check
MADSEN Zodiac PC Diagnostic Clinical
Madsen Zodiac PC Quick Check
ICS Aircal
VALUE LINE DCN Disposable Concentric Needle Electrodes
MADSEN A450
NATUS DANTEC Keypoint Focus EMG System
NATUS Madsen Alpha
BRIVIEW Disposable Electronic Flexible Choledochoscope
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD
BRIVIEW Imaging Processor System (Including Light Source)
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO LTD
RANDOX Total Antioxidant Status (TAS)
RANDOX LABORATORIES LIMITED
RANDOX Glutathione Peroxide (RANSEL)
RANDOX LABORATORIES LIMITED
RANDOX Ransel Control
RANDOX LABORATORIES LIMITED
RANDOX Glutathione Peroxide (RANSEL)
RANDOX LABORATORIES LIMITED
RANDOX Ransel Calibrator (RANSEL CAL)
RANDOX LABORATORIES LIMITED
RANDOX Serology III Positive Control (Serology III Control +)
RANDOX LABORATORIES LIMITED
RANDOX Serology I Positive Control (Serology I Control +)
RANDOX LABORATORIES LIMITED
RANDOX Serology II Positive Control (Serology II Control +)
RANDOX LABORATORIES LIMITED

