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HIGHTOP Lyse II - Indonesia BPOM Medical Device Registration

HIGHTOP Lyse II is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320721. The device is manufactured by QINGDAO HIGHTOP BIOTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GRACE REMAINS PROSPEROUS.

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
HIGHTOP Lyse II
Analysis ID: AKL 20208320721

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. GRACE REMAINS PROSPEROUS

AR Address

ANUGERAH TETAP MAKMUR

Registration Date

Sep 07, 2023

Expiry Date

May 20, 2028

Product Type

Hematological Reagents

Red cell lysing reagent.

Invitro Diagnostics

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