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GUARDIAN Inflatable Bone Expander System (Kyphoplasty System) - Indonesia BPOM Medical Device Registration

GUARDIAN Inflatable Bone Expander System (Kyphoplasty System) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302122027. The device is manufactured by BM KOREA CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ENDO INDONESIA.

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Risk Class Kelas Resiko : C
GUARDIAN Inflatable Bone Expander System (Kyphoplasty System)
Analysis ID: AKL 21302122027

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

BM KOREA CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. ENDO INDONESIA

AR Address

Jl. Raya Menganti 14

Registration Date

Apr 12, 2021

Expiry Date

Jan 31, 2026

Product Type

Prosthetic Orthopedic Equipment

Polymethylmethacrylate (PMMA) bone cement.

Non Electromedic Sterile

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