Otometrics Otoscan - Indonesia BPOM Medical Device Registration
Otometrics Otoscan is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10704320051. The device is manufactured by SYNCRON EMS from United States, and is classified as Risk Class Kelas Resiko : A. 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 : 1
Manufacturer
SYNCRON EMSCountry of Origin
United States
Authorized Representative
PT. CEKINDO BUSINESS INTERNATIONALAR Address
CEKINDO BUSINESS INTERNATIONAL
Registration Date
Feb 01, 2023
Expiry Date
Oct 18, 2027
Product Type
Therapeutic Ear, Nose and Throat Equipment
Ear, nose, and throat examination and treatment unit.
Non Radiation Electromedics
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

