BENCHMARK ULTRA and Accessories - Indonesia BPOM Medical Device Registration
BENCHMARK ULTRA and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20203912868. The device is manufactured by VENTANA MEDICAL SYSTEMS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ROCHE 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
VENTANA MEDICAL SYSTEMS INC.Country of Origin
United States
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Mar 24, 2023
Expiry Date
Dec 19, 2027
Product Type
Pathology Equipment and Accessories
Automated slide stainer.
Invitro Diagnostics
VENTANA HER2 Dual ISH 3-in-1 Xenograft Slides
VENTANA HybReady Solution
BENCHMARK GX and Accessories
VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody
VENTANA Anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
ULTRA Cell Conditioning Solution (ULTRA CC1)
ULTRA Cell Conditioning Solution (ULTRA CC2)
BENCHMARK XT AND Accessories
VENTANA Confirm anti-Topoisomerase II Alpha (JS5B4) Rabbit Monoclonal Primary Antibody
VENTANA Confirm anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody
Elecsys Anti-SARS-CoV-2 cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
PreciControl Maternal Care
ROCHE DIAGNOSTICS GMBH
COAGUCHEK aPTT Test
ROCHE DIAGNOSTICS GMBH.
ROCHE TROP T Sensitive, Troponin T
ROCHE DIAGNOSTICS GMBH.
COBAS BM - Lactate
ROCHE DIAGNOSTICS GMBH.
ultraView Universal Alkaline Phosphatase Red Detection Kit
VENTANA MEDICAL SYSTEMS, INC.
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.