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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.

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BPOM Registered
Risk Class Kelas Resiko : C
Kyphoplasty Balloon System (KYBS)
Analysis ID: AKL 21302420032

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

SKBIO NUSA MEDICA

AR 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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