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Emdyca

Infectious diseasesOther virology tests (infect. immunology/NAT)Herpes simplex virus

Hsv 1 igg

EMDN code W0105040306

26 manufacturers, 40 models including 40 on the market, 7 countries

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Manufacturers registered in Europe (EUDAMED) 26
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Gold Standard Diagnostics FDA Germany – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands) China – 98/79 Website EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 Website support@rayto.com EUDAMED record Report an error
Abbott FDA Ireland C IVDR Website EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@genesignbio.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia – 98/79 Website info@testlinecd.com EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
Aesku FDA Germany – 98/79 Website EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) China – 98/79 ra.rep@aichek.com EUDAMED record Report an error
Autobio Diagnostics FDA EU representative : QbD RepS BV (Belgium) China C IVDR info@autobio-diagnostics.com EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@cybereagen.com EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States – 98/79 Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Diesse FDA Italy C IVDR Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Human Germany – 98/79 Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR Website EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website info@realytech.com EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR Website info@szyhlo.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States C IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Technogenetics FDA Italy C IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Vircell Spain – 98/79 EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 13

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
Bio-Rad Present in Europe in other categories United States BioPlex 2200 Bio-Rad K120959 (2012)
CLARK LABORATORIES, INC. United States Trinity Biotech registered
Roche Diagnostics Corp. Present in Europe in other categories United States Elecsys HSV-1 IgG Elecsys HSV1 IgG Immunoassay K220923 (2022)
MONOBIND, INC. Present in Europe in other categories United States HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B) HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B) HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B) registered
Quest Intl., Inc. United States ReQuest SeraQuest K162276 (2016)
Diagnostic Automation, Inc. – AccuDiag ™ registered
ARLINGTON SCIENTIFIC, INC. United States – registered
BIOCHECK, INC. United States – registered
Biokit, S.A. Present in Europe in other categories Spain – K213987 (2023)
Diagnostic Automation /Cortez Diagnostics Inc. United States – registered
Roche Diagnostics Operations Inc. United States – registered
Trinity Biotech USA Present in Europe in other categories United States – K033105 (2004)
Zeus Scientific, Inc. Present in Europe in other categories United States – K103363 (2011)

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