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MACCURA Testosterone (CLIA) - Indonesia BPOM Medical Device Registration

MACCURA Testosterone (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324448. The device is manufactured by MACCURA BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. RESINS LABORATORIES.

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
MACCURA Testosterone (CLIA)
Analysis ID: AKL 20101324448

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. RESINS LABORATORIES

AR Address

Jl. Raya Bogor Km. 24,6

Registration Date

Dec 07, 2023

Expiry Date

May 17, 2026

Product Type

Clinical Chemistry Test System

Testosterone test system (kit & cair)

Invitro Diagnostics

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