Kyphoplasty Balloon System (KYBS) - Indonesia BPOM Medical Device Registration
Kyphoplasty Balloon System (KYBS) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302420032. The device is manufactured by OK MEDINET KOREA CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is SKBIO NUSA MEDICA.
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
OK MEDINET KOREA CO., LTD.Country of Origin
Korea
Authorized Representative
SKBIO NUSA MEDICAAR Address
KOMPLEK WIJAYA GRAHA PURI BLOK G NO. 17 LT. 3 JL. WIJAYA II, KEL. PULO KEC. KEBAYORAN BARU JAKARTA SELATAN
Registration Date
Feb 06, 2024
Expiry Date
Dec 04, 2027
Product Type
Prosthetic Orthopedic Equipment
Polymethylmethacrylate (PMMA) bone cement.
Non Electromedic Sterile
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KYBS (Kyphoplasty Balloon System) Osteo Toolkit Set
KYBS (Kyphoplasty Balloon System) Dilator Balloon
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