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GALAXY MIS Screw System - Indonesia BPOM Medical Device Registration

GALAXY MIS Screw System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302220506. The device is manufactured by BM KOREA CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. 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
GALAXY MIS Screw System
Analysis ID: AKL 21302220506

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BM KOREA CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. 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

Dec 06, 2022

Expiry Date

Jun 30, 2027

Product Type

Prosthetic Orthopedic Equipment

Pedicle screw spinal system

Non Electromedic Non Sterile

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