Pure Global

OSTHYONE Hip Prostheses - Indonesia BPOM Medical Device Registration

OSTHYONE Hip Prostheses is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320692. The device is manufactured by SHENZHEN BONE MEDICAL DEVICES 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 Hip Prostheses

OSTHYONE Hip Protheses

Analysis ID: AKL 21302320692

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 31, 2023

Expiry Date

Feb 23, 2026

Product Type

Prosthetic Orthopedic Equipment

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing