PROMEDS DIAGNOSTICS LYE-1 Lyse - Indonesia BPOM Medical Device Registration
PROMEDS DIAGNOSTICS LYE-1 Lyse is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208220286. The device is manufactured by SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PELITA MANDIRI SENTOSA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. PELITA MANDIRI SENTOSAAR Address
Jl. Boulevard Barat Raya, Komplek Kokan Inkopal KTC Blok F No. 66
Registration Date
Jul 07, 2024
Expiry Date
Jul 04, 2027
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
Dymind DM-5D SET Hematology Control
Dymind DM-5D Hematology Control L
DYMIND Hematology Control DM-BF Set
Dymind D-Dimer Control Low Value
PROMEDS DIAGNOSTICS PM-36H Auto Hematology Analyzer and Accessories
DYMIND D-80LD Hematology Analyzer Lyse
DYMIND D-80LN Hematology Analyzer Lyse
DYMIND D-80FD Hematology Analyzer Dye
Dymind D-80FR Hematology Analyzer Dye
DYMIND D-80DIL Hematology Analyzer Diluent
HORRON RD-171 Semi-Auto Chemistry Analyzer
SHENZHEN XILAIHENG MEDICAL ELECTRONINCS CO., LTD.
PROMEDS Diagnostics PM-Lyh Lyse-H
WHEISMAN MEDICAL TECHNOLOGY CO. LTD.
PROMEDS Diagnostics PM-DL Diluent
WHEISMAN MEDICAL TECHNOLOGY CO. LTD.
Promeds Diagnostics PM-Lyd Lyse-D
WHEISMAN MEDICAL TECHNOLOGY CO. LTD.
PROMEDS Diagnostics DIL-E Diluent
SHENZEN DYMIND BIOTECHNOLOGY CO., LTD
PROMEDS DIAGNOSTICS PM-36H Auto Hematology Analyzer and Accessories
SHENZHEN DYMIND BIOTECHNOLOGY CO., LTD.
PROMEDS DIAGNOSTICS CLP Cleanser
SHENZEN DYMIND BIOTECHNOLOGY CO., LTD
Promeds Diagnostics PM-610H 5-Part Auto Hematology Analyzer and Accessories
WHEISMAN MEDICAL TECHNOLOGY CO. LTD.
PROMEDS DIAGNOSTICS DOA-6 Panel Test Cup (AMP / BZD / COC / MET / MOR / THC)
XIAMEN BOSON BIOTECH CO., LTD.
PROMEDS Diagnostics THC Test Card
XIAMEN BOSON BIOTECH CO. LTD.

