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EVOLIS System - Indonesia BPOM Medical Device Registration

EVOLIS System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102320401. The device is manufactured by STRATEC SE from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.

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
EVOLIS System
Analysis ID: AKL 20102320401

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

STRATEC SE

Country of Origin

Germany

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Aug 02, 2023

Expiry Date

Sep 01, 2025

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

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