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SMILE Knee joint prosthesis - Indonesia BPOM Medical Device Registration

SMILE Knee joint prosthesis is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302124873. The device is manufactured by BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO., LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SEJAHTERA MEDIKA LESTARI.

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BPOM Registered
Risk Class Kelas Resiko : C
SMILE Knee joint prosthesis
Analysis ID: AKL 21302124873

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. SEJAHTERA MEDIKA LESTARI

AR Address

Jl. Jenderal Ahmad Yani No.17 RT.19/RW.10, Kode Pos 13120

Registration Date

Aug 07, 2024

Expiry Date

Jan 09, 2026

Product Type

Prosthetic Orthopedic Equipment

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

Non Electromedic Sterile

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