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ABX Pentra Enzymatic Creatinine CP - Indonesia BPOM Medical Device Registration

ABX Pentra Enzymatic Creatinine CP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101818782. 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 PT. 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 Enzymatic Creatinine CP
Analysis ID: AKL 20101818782

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Canada

Authorized Representative

PT. HORIBA INDONESIA

AR Address

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

Registration Date

Nov 18, 2022

Expiry Date

Oct 01, 2027

Product Type

Clinical Chemistry Test System

Creatinine test system (kit & cair)

Invitro Diagnostics

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