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SWELAB Lumi L1-Lyse - Indonesia BPOM Medical Device Registration

SWELAB Lumi L1-Lyse is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208420090. The device is manufactured by BOULE MEDICAL. from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NARWASTU MEDIKA.

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
SWELAB Lumi L1-Lyse
Analysis ID: AKL 20208420090

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BOULE MEDICAL.

Country of Origin

Sweden

Authorized Representative

PT. NARWASTU MEDIKA

AR Address

Jl. Daan Mogot km.20 No.411A Kelurahan Kebon Besar

Registration Date

May 20, 2024

Expiry Date

Feb 08, 2027

Product Type

Hematological Reagents

Red cell lysing reagent.

Invitro Diagnostics

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