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DrAccu PCT FIA - Indonesia BPOM Medical Device Registration

DrAccu PCT FIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303520111. The device is manufactured by ASSURE TECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PROSPEROUS BIOCARE.

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
DrAccu PCT FIA
Analysis ID: AKL 20303520111

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. PROSPEROUS BIOCARE

AR Address

RUKO KRANGGAN PERMAI BLOK RT 017/30

Registration Date

Feb 11, 2025

Expiry Date

Nov 21, 2028

Product Type

Serological Reagents

Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis

Invitro Diagnostics

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DJ Fang

DJ Fang

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