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BOULE Medonic M-Series Lyse, RFID - Indonesia BPOM Medical Device Registration

BOULE Medonic M-Series Lyse, RFID is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208918359. The device is manufactured by BOULE MEDICAL AB from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is MRK DIAGNOSTICS.

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Risk Class Kelas Resiko : B
BOULE Medonic M-Series Lyse, RFID
Analysis ID: AKL 20208918359

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BOULE MEDICAL AB

Country of Origin

Sweden

Authorized Representative

MRK DIAGNOSTICS

AR Address

JL. Merpati Mas I Blok B1 NO.46 Perkantoran Tanjung Mas Raya Tanjung Barat

Registration Date

Nov 24, 2023

Expiry Date

Dec 31, 2026

Product Type

Hematological Reagents

Red cell lysing reagent.

Invitro Diagnostics

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