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Emdyca

ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Mumps / parotitis virus

EMDN code W01050408

18 manufacturers, 36 models including 36 on the market, 12 countries

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Manufacturers registered in Europe (EUDAMED) 18
  • 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
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia – 98/79 Website info@testlinecd.com EUDAMED record Report an error
Diesse FDA Italy C IVDR Website EUDAMED record Report an error
Vircell Spain – 98/79 EUDAMED record Report an error
DiaSorin FDA Italy B IVDR, 98/79 Website EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Technogenetics FDA Italy C IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@am-diagnostics.co.uk EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye – 98/79 Website EUDAMED record Report an error
Bio-Rad Laboratories FDA EU representative : Bio-Rad (France) United States C IVDR Website contact@bio-rad.com EUDAMED record Report an error
bioMérieux FDA France – 98/79 EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website info@kogene.co.kr EUDAMED record Report an error
Poly Diagnostics Luxembourg B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Vitrosens Türkiye – 98/79 Website info@vitrosens.com 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) 12

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
CLARK LABORATORIES, INC. United States Trinity Biotech registered
Quest Intl., Inc. United States ReQuest SeraQuest K980059 (1998)
DRG Instruments Gesellschaft mit beschränkter Haftung – Mumps Virus IgG ELISA Mumps IgM ELISA registered
DRG International Inc United States Mumps IgM ELISA Mumps Virus IgG ELISA registered
ARLINGTON SCIENTIFIC, INC. United States ASI Mumps IgG EIA Test registered
Diagnostic Automation, Inc. – AccuDiag ™ registered
Diamedix Corp. United States Diamedix registered
BIOCHECK, INC. United States – registered
Calbiotech, Inc. United States – registered
Diagnostic Automation /Cortez Diagnostics Inc. United States – registered
Trinity Biotech USA Present in Europe in other categories United States – registered
Zeus Scientific, Inc. Present in Europe in other categories United States – K961204 (1996)

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