ROOTI Rx System - Indonesia BPOM Medical Device Registration
ROOTI Rx System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502120177. The device is manufactured by ROOTI LABS LIMITED from Taiwan (China), and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HARMONI PRIMA MEDIKA.
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
ROOTI LABS LIMITEDCountry of Origin
Taiwan (China)
Authorized Representative
PT. HARMONI PRIMA MEDIKAAR Address
Jl. Tanjung Selor No. 1A, Cideng, Gambir, Jakarta Pusat, 10150
Registration Date
Apr 28, 2022
Expiry Date
Jun 30, 2025
Product Type
Monitoring Cardiology Equipment
Radiofrequency physiological signal transmitter and receiver.
Non Radiation Electromedics
GRIP RX PTCA Catheter
ACROSTAK (SCHWEIZ) AG
ACROSS CTO PTCA Dilatation Catheter
ACROSTAK (SCHWEIZ) AG.
VERIFYNOW System and Accessories
ACCRIVA DIAGNOSTICS, INC.
ACROSS HP Rapid Exchange PTCA Catheter
ACROSTAK (SCHWEIZ) AG
ACROSS CTO RX Rapid Exchange PTCA Catheter
ACROSTAK (SCHWEIZ) AG
TRICELL PRP Kit
REV-MED INC.
YUKON Choice PC
TRANSLUMINA GMBH.
YUKON Chrome PC
TRANSLUMINA GMBH.
GENXSYNC Sirolimus Eluting Coronary Stent
PURPLE MICROPORT CARDIOVASCULAR PRIVATE LIMITED
M-CATH Microcatheter
ACROSTAK (SCHWEIZ) AG.