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SMILE Hip Joint Prosthesis - Indonesia BPOM Medical Device Registration

SMILE Hip Joint Prosthesis is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302122198. 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.

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
SMILE Hip Joint Prosthesis
Analysis ID: AKL 21302122198

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

Mar 13, 2024

Expiry Date

Mar 11, 2027

Product Type

Prosthetic Orthopedic Equipment

Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Non Electromedic Sterile

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