Pure Global

OSTHYONE Knee Arthroplasty Instrument - Indonesia BPOM Medical Device Registration

OSTHYONE Knee Arthroplasty Instrument is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11303420032. The device is manufactured by SHENZHEN BONE MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. 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 : A
OSTHYONE Knee Arthroplasty Instrument
Analysis ID: AKL 11303420032

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

China

Authorized Representative

PT. MAGNIFICENT DINAR CALAKAN

AR Address

Jl. Danita 2 Kav 2 RT 015 RW 013, Kel. Bekasijaya, Kec. Bekasi Timur, Kota Bekasi, Jawa Barat

Registration Date

Jan 31, 2024

Expiry Date

Feb 23, 2026

Product Type

Surgical Orthopaedic Equipment

Orthopedic manual surgical instrument.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing