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Emdyca

ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)

Staphylococci

EMDN code W01050112

25 manufacturers, 45 models including 43 on the market, 14 countries

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Manufacturers registered in Europe (EUDAMED) 25
  • 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
gerbion Germany
1 other
 – 98/79 info@gerbion.com EUDAMED record Report an error
ZeptoMetrix FDA EU representative : Emergo Europe B.V. (Netherlands) United States B IVDR Website EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other Australia – 98/79 Website regulatory@r-biopharm.com.au 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
Abacus Diagnostica Finland – 98/79 info@abacusdiagnostica.com EUDAMED record Report an error
Hain Lifescience Germany C IVDR, 98/79 EUDAMED record Report an error
Pro-Lab Diagnostics EU representative : Advena Limited (Malta) Canada – 98/79 Website support@pro-lab.com EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain) China – 98/79 sale@rocgene.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States C IVDR Website EUDAMED record Report an error
Bio-Rad FDA France B IVDR Website contact@bio-rad.com EUDAMED record Report an error
Cepheid FDA Sweden – 98/79 Website EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 sales@coyotebio.com EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States C IVDR EUDAMED record Report an error
Poly Diagnostics Luxembourg B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Pro-Lab Diagnostics UK EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website EUDAMED record Report an error
R-Biopharm FDA Germany C IVDR Website EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR Website EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 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
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany) Singapore – 98/79 Website infoAPAC@veladx.com EUDAMED record Report an error
Vitassay Spain – 98/79 Website info@vitassay.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Uniogen No model still on the market Finland – 98/79 info@uniogen.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) 5

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
PRO-LAB, INCORPORATED Present in Europe in other categories Canada Prolex Staph Kit (300 Tests) Prolex Latex Reagent Control Negative (Staph) Prolex Staph Kit (100 tests) Prolex Staph Xtra Latex Kit (300 tests) Prolex Staph Xtra Latex Kit (100 tests) Prolex Staph Positive Control registered
HARDY DIAGNOSTICS United States StaphTEX™ registered
Oxoid U.S.A., Inc. Present in Europe in other categories United States SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests K855233 (1986)
Remel Co. Present in Europe in other categories United States Staphaurex (400 test) Staphaurex (120 test) registered
Princeton BioMeditech Corp. Present in Europe in other categories United States – registered

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