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ABX Pentra HDL Direct CP - Indonesia BPOM Medical Device Registration

ABX Pentra HDL Direct CP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324644. The device is manufactured by SEKISUI DIAGNOSTICS P.E.I. INC from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is HORIBA INDONESIA.

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 : B
ABX Pentra HDL Direct CP
Analysis ID: AKL 20101324644

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Canada

Authorized Representative

HORIBA INDONESIA

AR Address

Jl. Jalur Sutera , Blok. 20A, No. 16 - 17, Kel. Kunciran, Kec. Pinang

Registration Date

Dec 27, 2023

Expiry Date

Nov 15, 2028

Product Type

Clinical Chemistry Test System

Lipoprotein test system (kit & cair)

Invitro Diagnostics

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