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ACTIS Duofix Hip Prosthesis - Indonesia BPOM Medical Device Registration

ACTIS Duofix Hip Prosthesis is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302420316. The device is manufactured by DEPUY ORTHOPAEDICS, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. JOHNSON AND JOHNSON INDONESIA TWO.

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
ACTIS Duofix Hip Prosthesis
Analysis ID: AKL 21302420316

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. JOHNSON AND JOHNSON INDONESIA TWO

AR Address

K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A.

Registration Date

Aug 26, 2024

Expiry Date

Feb 21, 2028

Product Type

Prosthetic Orthopedic Equipment

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

Non Electromedic Sterile

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