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CARLON Kyphoplasty System - Indonesia BPOM Medical Device Registration

CARLON Kyphoplasty System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302125905. The device is manufactured by JIANGSU TRAUHUI MEDICAL INSTRUMENT CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is WIJAYA MITRA HUSADA.

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
CARLON Kyphoplasty System
Analysis ID: AKL 21302125905

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

WIJAYA MITRA HUSADA

AR Address

Jln. Sirojul Munir, Kp Cakung, Perum Pualam Green Village, Kav 2, RT 004/03, Jatisari, Jati Asih, Kota Bekasi

Registration Date

Feb 26, 2024

Expiry Date

Jan 23, 2027

Product Type

Prosthetic Orthopedic Equipment

Polymethylmethacrylate (PMMA) bone cement.

Non Electromedic Sterile

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