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DBESTOne Step Rapid Test Neonatal TSH Whole Blood - Indonesia BPOM Medical Device Registration

DBESTOne Step Rapid Test Neonatal TSH Whole Blood is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101813547. The device is manufactured by AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.

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
DBESTOne Step Rapid Test Neonatal TSH Whole Blood
Analysis ID: AKL 20101813547

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. FAITHFUL MEDICAL GRACE

AR Address

Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89

Registration Date

Jun 02, 2020

Expiry Date

Apr 06, 2025

Product Type

Clinical Chemistry Test System

Thyroid stimulating hormone test system (card)

Invitro Diagnostics

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