BIOCARE PAX8 (M) - Indonesia BPOM Medical Device Registration
BIOCARE PAX8 (M) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20201220027. The device is manufactured by BIOCARE MEDICAL LLC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BIOZATIX INDONESIA.
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
BIOCARE MEDICAL LLCCountry of Origin
United States
Authorized Representative
PT. BIOZATIX INDONESIAAR Address
Jl. Griya Agung No.59 RT 02 RW 020
Registration Date
Mar 09, 2022
Expiry Date
Dec 31, 2026
Product Type
Biological Dyes
Immunohistochemistry reagents and kits (Quantitative).
Invitro Diagnostics
BIOCARE GATA-3
BIOCARE Antigen Retrieval Chamber High Voltage (ARCHV)
BIOCARE - Epithelial Membrane Antigen (EMA) [E29]
BIOCARE - ATRX
BIOCARE - CD1a [O10]
BIOCARE - Lambda Light Chain [N10/2]
BIOCARE - Granzyme B
BIOCARE - Kappa Light Chain [L1C1]
BIOCARE - CD 23
BIOCARE - SATB2 [CL0323]
MYR- MODULAR TISSUE EMBEDDING CENTER (Cryo Console)
ESPECIALIDADES MEDICAS MYR, SL
MYR - SEMI-AUTOMATED ROTARY MICROTOME
ESPECIALIDADES MEDICAS MYR, SL
MYR - FULLY AUTOMATED ROTARY MICROTOME
ESPECIALIDADES MEDICAS MYR, SL
BIOCARE GATA-3
BIOCARE MEDICAL LLC
MEDAX - Biopsy Needle mod. MIELOX
MEDAX S.R.L UNIPERSONALE
MEDAX Biopsy Needle mod. BIO-FEATHER
MEDAX S.R.L. UNIPERSONALE
MEDAX - Biopsy Needle mod. UNICORE
MEDAX S.R.L UNIPERSONALE
MEDAX - Automatic Reuseable System Biopsy Gun, Mod. MEDCORE
MEDAX S.R.L. UNIPERSONALE
BIOCARE Antigen Retrieval Chamber High Voltage (ARCHV)
BIOCARE MEDICAL LLC
BIOCARE - ATRX
BIOCARE MEDICAL LLC