Pure Global

OSTHYONE Intramedullary Nails Systems - Indonesia BPOM Medical Device Registration

OSTHYONE Intramedullary Nails Systems is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320663. The device is manufactured by CANWELL MEDICAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAGNIFICENT DINAR CALAKAN.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
OSTHYONE Intramedullary Nails Systems
Analysis ID: AKL 21302320663

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MAGNIFICENT DINAR CALAKAN

AR Address

Citra Swarna Regency, Jalan Melati Raya Barat

Registration Date

May 08, 2023

Expiry Date

May 04, 2026

Product Type

Prosthetic Orthopedic Equipment

Intramedullary fixation rod.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing