ERBA H360 Lyse - Indonesia BPOM Medical Device Registration
ERBA H360 Lyse is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208220098. The device is manufactured by ERBA LACHEMA S.R.O. from Czech Republic, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ELBA LAB 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
ERBA LACHEMA S.R.O.Country of Origin
Czech Republic
Authorized Representative
ELBA LAB MEDIKAAR Address
GRAHA BUMI INDAH LANTAI II ROOM 2005, JL. RAYA KALIMALANG KAV. AGRARIA NO. 8-0 RT/RW 002/016 KEL. DUREN SAWIT KEC. DUREN SAWIT JAKARTA TIMUR
Registration Date
May 13, 2022
Expiry Date
Sep 05, 2024
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
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ERBA Norm 4x5
ERBA Mannheim XL SysPack LDL C 80
ERBA Mannheim XL SysPack CHOL 440
ERBA Mannheim XL SysPack AST/GOT 330
PENRUI Hematology Control Normal 5 Diff
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