Instrument intended for immunoassays - ANVISA Registration 80003610566
Access comprehensive regulatory information for Instrument intended for immunoassays in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80003610566 and manufactured by INOVA DIAGNOSTICS, INC.. The registration is held by WERFEN MEDICAL LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including HANGZHOU ALLTEST BIOTECH CO. LTD, ACRO BIOTECH, INC. (MONTCLAIR), and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
80003610566
25351812387201828
02004662000165
Company Information
Dates and Status
Feb 18, 2019
VIGENTE
09/18/2025 19:00:01
Instrument intended for immunoassays
QWALYS
DIAGAST
10234400231
Nov 26, 2018
Instrument intended for immunoassays
LABOTECH
ADALTIS
80345000220
Apr 11, 2011
Instrument intended for immunoassays
RIDA® Q3
R-BIOPHARM AG
82890930013
Jul 07, 2025
Instrument for analysis of general biochemistry, hormones, drugs or proteins
QUANTA-LYSER
INOVA DIAGNOSTICS, INC.
80003610436
Sep 29, 2014
Instrument intended for immunoassays
Merilyzer EiaQuant ™
MERIL DIAGNOSTIC PVT LTD.
10360810067
Nov 27, 2023
HANGZHOU ALLTEST BIOTECH CO. LTD• China
ACRO BIOTECH, INC. (MONTCLAIR)• United States of America
DIAMED GMBH• Switzerland
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD• China
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