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Manufacturer profile

ORGENTEC DIAGNOSTIKA GMBH

BrazilGermany266 ANVISA registrations39 unique technical categoriesMay 20, 2019 – Jul 06, 2026
Verified
266
Total products
39
Technical names
May 2019
Earliest registration
Jul 2026
Latest registration
Regulatory footprint
Search ORGENTEC DIAGNOSTIKA GMBH across other regulatory registries
ThailandEuropean UnionVietnamSouth KoreaEcuadorUnited States
Recent registrations
Latest 5 products registered by this manufacturer
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
Anti-SS-A 60
Class II · Jul 06, 2026
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ORG 260 Anti-SS-A 60
Class II · Jul 06, 2026
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
ORG 652 Anti-SS-A 52
Class II · Jul 06, 2026
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
Anti-SS-A 52
Class II · Jul 06, 2026
MUMPS VIRUS
Anti-Mumps Virus IgM Abs.
Class II · May 18, 2026
Most popular products
Products with most registrations
ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA)
44 registrations
ANTIPHOSPHOLIPID ANTIBODY
31 registrations
ANTINUCLEAR ANTIBODY (ANA)
25 registrations
ANTIBODY FOR CELIAC DISEASE
25 registrations
ANTICYTOPLASMIC ANTIBODY
17 registrations
Top registration holders
Companies holding product registrations for this manufacturer
SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO LTDA.
140 products
VYTTRA DIAGNOSTICOS S.A.
118 products
Top competitors
Companies with the most overlapping products (same technical names)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
China
56 registrations23 shared products
Shared products
25 HYDROXYVITAMIN D3 OF VITAMIN D, ANTI-CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP), ANTI-INSULIN ANTIBODY, ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA), ANTIBODY FOR CELIAC DISEASE, ANTICARDIOLIPIN, ANTICENTROMERE ANTIBODY, ANTICYTOPLASMIC ANTIBODY, ANTIMITOCHONDRIAL ANTIBODY, ANTINUCLEAR ANTIBODY (ANA), ANTIPHOSPHOLIPID ANTIBODY, ANTITHYROID ANTIBODY (ANTI-TPO), CHLAMYDIA, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, HELICOBACTER PYLORI, HERPES VIRUS (HHV 1), HERPES VIRUS (HHV 2), HISTONE, Instrument intended for immunoassays, MYCOPLASMA, RUBELLA VIRUS, SOLUÇÃO PARA AVALIAÇÃO DE DESEMPENHO DOS COMPONENTES DE EQUIPAMENTOS, THYROGLOBULIN (TG)
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
Germany
67 registrations20 shared products
Shared products
ANTI-GLOMERULAR BASEMENT MEMBRANE ANTIBODY (GBM), ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA), ANTIBODY FOR CELIAC DISEASE, ANTICARDIOLIPIN, ANTICYTOPLASMIC ANTIBODY, ANTINUCLEAR ANTIBODY (ANA), BORDETELLA PERTUSSIS, CHLAMYDIA, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, FLASK OR MATERIAL FOR COLLECTION, STORAGE OR TRANSPORT OF BIOLOGICAL SAMPLES, HERPES VIRUS (HHV 1), HERPES VIRUS (HHV 2), HERPES VIRUS (HHV 3) - VARICELLA ZOSTER, Instrument intended for immunoassays, MEASLES, MYCOPLASMA, PARIETAL CELL ANTIBODY, PARVOVIRUS B 19, RUBELLA VIRUS, SYSTEMIC LUPUS ERYTHEMATOSUS
EUROIMMUN AG
Germany
59 registrations20 shared products
Shared products
25 HYDROXYVITAMIN D3 OF VITAMIN D, ANTI-ASCA ANTIBODY, ANTI-CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP), ANTI-INTRINSIC FACTOR ANTIBODY, ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA), ANTIBODY FOR CELIAC DISEASE, ANTICARDIOLIPIN, ANTICYTOPLASMIC ANTIBODY, ANTIMITOCHONDRIAL ANTIBODY, ANTINUCLEAR ANTIBODY (ANA), ANTIPHOSPHOLIPID ANTIBODY, AUTOIMMUNE HEPATITIS (AIH) ANTIBODY, C1Q COMPONENT COMPLEMENT, CALPROTECTIN, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, HELICOBACTER PYLORI, HISTONE, Instrument intended for immunoassays, MUMPS VIRUS, SYSTEMIC LUPUS ERYTHEMATOSUS
PHADIA AB
Sweden
60 registrations18 shared products
Shared products
ANTI-ASCA ANTIBODY, ANTI-CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP), ANTI-GLOMERULAR BASEMENT MEMBRANE ANTIBODY (GBM), ANTI-INTRINSIC FACTOR ANTIBODY, ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA), ANTIBODY FOR CELIAC DISEASE, ANTICARDIOLIPIN, ANTICENTROMERE ANTIBODY, ANTICYTOPLASMIC ANTIBODY, ANTIMITOCHONDRIAL ANTIBODY, ANTINUCLEAR ANTIBODY (ANA), ANTIPHOSPHOLIPID ANTIBODY, ANTITHYROID ANTIBODY (ANTI-TPO), CALPROTECTIN, COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II, Instrument intended for immunoassays, PARIETAL CELL ANTIBODY, RHEUMATOID FACTOR
INOVA DIAGNOSTICS, INC.
United States
73 registrations17 shared products
Shared products
ANTI-CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP), ANTI-GLOMERULAR BASEMENT MEMBRANE ANTIBODY (GBM), ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA), ANTIBODY FOR CELIAC DISEASE, ANTICARDIOLIPIN, ANTICYTOPLASMIC ANTIBODY, ANTIMITOCHONDRIAL ANTIBODY, ANTINUCLEAR ANTIBODY (ANA), ANTIPHOSPHOLIPID ANTIBODY, AUTOIMMUNE HEPATITIS (AIH) ANTIBODY, CALPROTECTIN, FLASK OR MATERIAL FOR COLLECTION, STORAGE OR TRANSPORT OF BIOLOGICAL SAMPLES, HISTONE, Instrument intended for immunoassays, PARIETAL CELL ANTIBODY, RHEUMATOID FACTOR, SYSTEMIC LUPUS ERYTHEMATOSUS
About this profile

Explore comprehensive manufacturer profile for ORGENTEC DIAGNOSTIKA GMBH based in Germany through Pure Global AI's free Brazil medical device database. This manufacturer has 266 products registered with ANVISA across 39 unique technical categories. Their regulatory history spans from May 20, 2019 to Jul 06, 2026.

This page provides detailed insights including 5 recent product registrations including ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA), 5 most popular products with ANTIBODY ANTI-EXTRACTABLE NUCLEAR ANTIGENS (ENA) having 44 registrations, 2 registration holders including SEBIA IMPORTAÇÕES COMERCIALIZAÇÃO E DISTRIBUIÇÃO DE APARELHOS E REATIVOS PARA DIAGNÓSTICO IN VITRO LTDA., and 5 key competitors with SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. sharing 23 products. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, enabling global MedTech companies to analyze market dynamics and identify opportunities.