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Emdyca

ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)

Mycoplasma / ureaplasma

EMDN code W01050108

74 manufacturers, 212 models including 197 on the market, 14 countries

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Manufacturers registered in Europe (EUDAMED) 74
  • 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
TestLine Clinical Diagnostics s.r.o Czechia
19 others
 B IVDR, 98/79 Website info@testlinecd.com EUDAMED record Report an error
Vitrosens Türkiye
7 others
 B, C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Vircell Spain
6 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Astra Biotech Germany
1 other
 – 98/79 Website info@astrabiotech.de EUDAMED record Report an error
GenDx FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China, United States
1 other
 – 98/79 Website orders@genbio.com EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany
1 other
 – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
1 other
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Vidia Czechia
1 other
 – 98/79 Website EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye
1 other
 B, C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Geneproof Czechia C IVDR, 98/79 Website support@geneproof.com EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other China – 98/79 office@guoke-medical.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States – 98/79 quality@healgen.com 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
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) United States – 98/79 info@acrobiotech.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Diesse FDA Italy C IVDR Website EUDAMED record Report an error
Dynamiker EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China – 98/79 Website marketing@dynamiker.com EUDAMED record Report an error
Ecolidx Czechia – 98/79 Website EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Labsystems Diagnostics FDA Finland – 98/79 Website EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Certest Spain B, C IVDR Website quality@certest.es 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 Italy B IVDR, 98/79 Website EUDAMED record Report an error
Eurospital FDA Italy – 98/79 regulatory@eurospital.it EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@genesignbio.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website info@gensurebio.com EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Hightopbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) China B IVDR Website EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China B IVDR, 98/79 Website EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@rapidlabs.co.uk 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
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
XEMA EU representative : Polmed.de Beata Rozwadowska (Germany) Russia – 98/79 Website EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Ab Analitica Italy – 98/79 customersupport@abanalitica.it EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany) China – 98/79 EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain) China – 98/79 sales@dbluemedical.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website contact@diareagent.com EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany) China B IVDR Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website marketing@boditech.co.kr EUDAMED record Report an error
Bosonbio FDA EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Diagreat EU representative : Medunion S.L. (Spain) China B IVDR Website info@diagreat.com EUDAMED record Report an error
Elisabeth Czechia – 98/79 Website info@elisabeth.cz EUDAMED record Report an error
ElitechGroup FDA Italy C IVDR Website EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Eurobio Scientific France – 98/79 reglementaire@eurobio-scientific.com EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@fanttest.com EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 info@biotests.com.cn EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 ra.danwei@danwei-bio.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Canada – 98/79 sales@orientgene.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States C IVDR EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium) China – 98/79 Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 marketing@hongweitest.com EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany) China – 98/79 EUDAMED record Report an error
Pluslife EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 Website ra@pluslife.com EUDAMED record Report an error
R-Biopharm FDA Germany – 98/79 Website EUDAMED record Report an error
SpeeDx FDA EU representative : MedEnvoy Global BV (Netherlands) Australia C IVDR Website regulatory@speedx.com.au EUDAMED record Report an error
TIB MOLBIOL Syntheselabor Germany – 98/79 Website EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China C IVDR Website service@bioustar.com EUDAMED record Report an error
Vitassay Spain – 98/79 Website info@vitassay.com EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium) China – 98/79 EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China
6 others
 – 98/79 EUDAMED record Report an error
Biotime EU representative : Medunion S.L. (Spain) No model still on the market China – 98/79 EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) No model still on the market China – 98/79 Website info@sansure.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) 11

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
Genbio United States ImmunoFLOW Negative Control Mycoplasma IgM IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test ImmunoFLOW Mycoplasma IgM Positive Control ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST K963054 (1997)
SAVYON DIAGNOSTICS LTD Israel SeroMP IgM SeroMP IgA SeroMP IgG registered
CLARK LABORATORIES, INC. United States Trinity Biotech registered
DRG Instruments Gesellschaft mit beschränkter Haftung – Mycoplasma pneumoniae IgG ELISA registered
DRG International Inc United States Mycoplasma pneumoniae IgG ELISA registered
Diagnostic Automation, Inc. – AccuDiag ™ registered
Diamedix Corp. United States Diamedix registered
Meridian Bioscience, Inc. Present in Europe in other categories United States ImmunoCard Mycoplasma registered
BIOCHECK, INC. United States – registered
Diagnostic Automation /Cortez Diagnostics Inc. United States – registered
Zeus Scientific, Inc. Present in Europe in other categories United States – K984153 (1999)

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