SUNOPTIC HD Headlight Camera System - Indonesia BPOM Medical Device Registration
SUNOPTIC HD Headlight Camera System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20801220184. The device is manufactured by SUNOPTIC TECHNOLOGIES LLC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PERMATA MEDIKA PRIMA.
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
SUNOPTIC TECHNOLOGIES LLC.Country of Origin
United States
Authorized Representative
PT. PERMATA MEDIKA PRIMAAR Address
JL. HOS COKROAMINOTO, PERTOKOAN CBD CILEDUG BLOK A3 NO. 30, RT.001/RW.001
Registration Date
Dec 14, 2023
Expiry Date
Dec 31, 2025
Product Type
Diagnostic Gastroenterology-Urology Equipment
Endoscope and accessories.
Non Radiation Electromedics
DE SOUTTER MEDICAL MBC-709 Sternudrive Lite Modular Handpiece
DE SOUTTER MEDICAL LTD.
STERNUDRIVE DBC-470 Battery Sternum Saw - Less Guard
DE SOUTTER MEDICAL LTD.
CENTROSFLO Long-Term Hemodialysis Catheter
MERIT MEDICAL SYSTEMS, INC.
MERIT PAK Pedal Access Kit Hydrophilic
MERIT MEDICAL SYSTEMS, INC.,
MERIT MAK Mini Access Kit
MERIT MAQUILADORA MEXICO, S. DE R.L DE C.V.
PRELUDE Short Sheath Introducer
MERIT MEDICAL SYSTEMS, INC.
SUNOPTIC Xenon Light Sources Titan X300
SUNOPTIC TECHNOLOGIES LLC.
HeRO Graft
MERIT MEDICAL SYSTEMS, INC.

