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Qualcyte 10 ESR Auto Analyzer - Indonesia BPOM Medical Device Registration

Qualcyte 10 ESR Auto Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10205320412. The device is manufactured by SPEROGENX BIOSCIENCES PVT. LTD from India, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. SABA INDOMEDIKA.

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 : A
Qualcyte 10 ESR Auto Analyzer
Analysis ID: AKL 10205320412

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

India

Authorized Representative

PT. SABA INDOMEDIKA

AR Address

Ruko Kedoya Elok Plaza DB-33 Jl. Panjang No.7-9

Registration Date

Jul 17, 2023

Expiry Date

Jul 03, 2025

Product Type

Automatic and Semi-Automatic Hematology Equipment

Automated sedimentation rate device.

Invitro Diagnostics

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