OPRHEE MYTH-3D - Indonesia BPOM Medical Device Registration
OPRHEE MYTH-3D is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208125319. The device is manufactured by R & D SYSTEM INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOLABTEK DYNAMICS.
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.
OPRHEE MYT-3D
Risk Classification
Product Class
Kelas : 2
Manufacturer
R & D SYSTEM INC.Country of Origin
United States
Authorized Representative
PT. INDOLABTEK DYNAMICSAR Address
Rukan Royal Palace B-25. JL. Prof. Dr. Soepomo. SH, No. 178A. Menteng Dalam. Jakarta Selatan.
Registration Date
Jun 23, 2023
Expiry Date
May 11, 2028
Product Type
Hematological Reagents
Hematology quality control mixture.
Invitro Diagnostics
NIHON KOHDEN MEK-3DN Normal Hematology Control
NIHON KOHDEN MEK-5D Hematology Control for Five Part Differential
NIHON KOHDEN MEK-5DN Hematology Control for Five Part Differential
MYT-3D Normal Level
NIHON KOHDEN MEK-3DL and MEK-3DH Hematology Control
AGNITIO BioIC Analyzer
AGNITIO SCIENCE & TECHNOLOGY INC.
BIOIC Allergen Specific-IgE Detection kit
AGNITIO SCIENCE AND TECHNOLOGY, INC.
Mythic 18-22 Flush-Cleaner
PZ CORMAY S.A.
MYT-3D Normal Level
R & D SYSTEM INC.
MYTHIC 18 Cyanide Free Lytic Solution
PZ CORMAY S.A
MYTHIC 18 Diluent
PZ CORMAY S.A.
ORPHEE Mythic 18 Hematology Analyzer Automated
BIT ANALYTICAL INSTRUMENTS
MYTHIC 18-22 Enzymatic Cleaning Solution
PZ CORMAY S.A

