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P.F.C Sigma Knee System - Indonesia BPOM Medical Device Registration

P.F.C Sigma Knee System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320870. 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 JOHNSON AND JOHNSON INDONESIA TWO.

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BPOM Registered
Risk Class Kelas Resiko : C
P.F.C Sigma Knee System
Analysis ID: AKL 21302320870

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

JOHNSON AND JOHNSON INDONESIA TWO

AR Address

K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950

Registration Date

Sep 07, 2023

Expiry Date

Feb 21, 2028

Product Type

Prosthetic Orthopedic Equipment

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

Non Electromedic Sterile

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