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Registration holder profile

ORBITAE DIAGNOSTICOS S/A

Brazil108 ANVISA registrations54 unique technical categoriesDec 01, 2014 – Sep 21, 2026
Verified
108
Total products
54
Technical names
Dec 2014
Earliest registration
Sep 2026
Latest registration
Regulatory footprint
Search ORBITAE DIAGNOSTICOS S/A across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Recent registrations
Latest 5 products registered by this holder
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
PSA FIA Assure Test
Class III · Sep 21, 2026
MYOGLOBIN
Mioglobina FIA Assure Test
Class III · Jan 19, 2026
TROPONIN
Troponina I FIA Assure Test
Class III · Dec 29, 2025
TROPONIN
hs-cTnI (Troponina Ultrassensível) FIA Assure Test
Class III · Dec 08, 2025
THYROID STIMULATING HORMONE (TSH)
TSH FIA Assure Test
Class II · Dec 01, 2025
Most popular products
Products with most registrations
DRUGS OF ABUSE PANEL
27 registrations
CORONAVIRUS
10 registrations
Instrument intended for immunoassays
4 registrations
TOTAL CHOLESTEROL
3 registrations
SELF-TEST FOR SARS-COV-2 ANTIGEN (CORONAVIRUS)
3 registrations
Top manufacturers
Manufacturers with the most products registered by this holder
ASSURE TECH. (HANGZHOU) CO., LTD
35 products
ASSURE TECH. (HANGZHOU) CO., LTD.
21 products
ASSURE TECH. HANGZHOU CO., LTD.
11 products
ALFA SCIENTIFIC DESIGNS INC.
10 products
TASCOM CO., LTD
9 products
Products per risk level
Distribution of distinct commercial products by ANVISA risk classification
Class I2Distinct Products · 2 total registrations
Class II68Distinct Products · 68 total registrations
Class III29Distinct Products · 29 total registrations
Class IV9Distinct Products · 9 total registrations
About this profile

Access comprehensive registration holder profile for ORBITAE DIAGNOSTICOS S/A through Pure Global AI's free Brazil medical device database. This registration holder manages 108 medical device registrations with ANVISA across 54 unique technical categories. Their regulatory portfolio spans from Dec 01, 2014 to Sep 21, 2026.

This page provides comprehensive insights including 5 recent product registrations, 5 most popular products led by DRUGS OF ABUSE PANEL with 27 registrations, partnerships with 5 key manufacturers including ASSURE TECH. (HANGZHOU) CO., LTD and ASSURE TECH. (HANGZHOU) CO., LTD., and products across 4 risk classifications with 2 Class I devices. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping distributors understand market dynamics and identify business opportunities.