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BT LOOP Adjustable Fixation System for Ligament Reconstruction - Indonesia BPOM Medical Device Registration

BT LOOP Adjustable Fixation System for Ligament Reconstruction is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302122264. The device is manufactured by S.B.M. SAS from France, 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
BT LOOP Adjustable Fixation System for Ligament Reconstruction
Analysis ID: AKL 21302122264

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

S.B.M. SAS

Country of Origin

France

Authorized Representative

PT. ENDO INDONESIA

AR Address

Jl. Raya Menganti 14

Registration Date

Apr 20, 2021

Expiry Date

Dec 15, 2025

Product Type

Prosthetic Orthopedic Equipment

Smooth or threaded metallic bone fixation fastener.

Non Electromedic Sterile

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