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BFIX External Fixator System (2) - Indonesia BPOM Medical Device Registration

BFIX External Fixator System (2) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302122625. The device is manufactured by AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ENDO INDONESIA.

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
BFIX External Fixator System (2)
Analysis ID: AKL 21302122625

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ENDO INDONESIA

AR Address

Jl. Raya Menganti 14

Registration Date

Apr 08, 2022

Expiry Date

May 06, 2025

Product Type

Prosthetic Orthopedic Equipment

Single/multiple component metallic bone fixation appliances and accessories.

Non Electromedic Non Sterile

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