SWELAB Lumi and Accessories - Indonesia BPOM Medical Device Registration
SWELAB Lumi and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205912487. 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
BOULE MEDICAL.Country of Origin
Sweden
Authorized Representative
PT. NARWASTU MEDIKAAR Address
Jl. Daan Mogot km.20 No.411A Kelurahan Kebon Besar
Registration Date
Mar 20, 2024
Expiry Date
Feb 08, 2027
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated differential cell counter
Invitro Diagnostics
SWELAB Lumi L1-Lyse
LUMILAB BOULE Cal-5Diff A1
SWELAB Snow-D Diluent
BOULE Medonic M-series Diluent
MEDONIC M51-D Diluent
BOULE Medonic M-series Lyse
BOULE Con-5Diff A1 Norm
BALL Cal-5Diff A1
BOULE Medonic M-Series Dualpack, RFID
BOULE Medonic M-Series Diluent, RFID
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