SWELAB LUMI-L2 Lyse - Indonesia BPOM Medical Device Registration

SWELAB LUMI-L2 Lyse is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208915726. The device is manufactured by BOULE MEDICA. from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NARWASTU MEDIKA.

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BPOM Registered

Risk Class Kelas Resiko : B

SWELAB LUMI-L2 Lyse

Analysis ID: AKL 20208915726

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

Country of Origin

Sweden

Authorized Representative

PT. NARWASTU MEDIKA

AR Address

Jl Daan Mogot Km.20 No.411A

Registration Date

Jan 12, 2022

Expiry Date

Jun 01, 2024

Product Type

Hematological Reagents

Red cell lysing reagent.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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