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SHARAY Insulin (CLIA) - Indonesia BPOM Medical Device Registration

SHARAY Insulin (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101420968. The device is manufactured by C-LUMINARY BIOTECHNOLOGY 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
SHARAY Insulin (CLIA)
Analysis ID: AKL 20101420968

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

May 21, 2024

Expiry Date

Jul 28, 2028

Product Type

Clinical Chemistry Test System

Immunoreactive insulin test system (kit & cair)

Invitro Diagnostics

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