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Emdyca

IVD instrumentsMicrobiology instruments (cultures)

Mass - spectrometry system

EMDN code W020303

10 manufacturers, 36 models including 36 on the market, 8 countries

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Manufacturers registered in Europe (EUDAMED) 10
  • 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
bioMérieux FDA EU representative : bioMérieux SA (France) France, United States
3 others
 A, B IVDR, 98/79 EUDAMED record Report an error
Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany) Japan
2 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium) China
1 other
 C IVDR Website EUDAMED record Report an error
Bruker FDA Germany A IVDR Website info.md@bruker.com EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium) and 1 other China C IVDR, 98/79 PMS@zy-ivd.com EUDAMED record Report an error
ASTA EU representative : Emergo Europe B.V. (Netherlands) South Korea C IVDR, 98/79 Website EUDAMED record Report an error
Sciex FDA EU representative : Leica Microsystems CMS GmbH (Germany) Singapore A IVDR EUDAMED record Report an error
Ascend Diagnostics EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website EUDAMED record Report an error
Guangzhou Topms Technology EU representative : Share info GmbH (Germany) China A IVDR EUDAMED record Report an error
Waters FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR 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
Bruker Daltonik GmbH Germany MBT Pilot System - US IVD MALDI Biotyper sirius CA System MALDI Biotyper-BD sirius CA System MALDI Biotyper CA System MALDI Biotyper-BD sirius one CA System MALDI Biotyper sirius one CA System K163536 (2017)
AGENA BIOSCIENCE, INC. United States SpectroChip Standalone Chip Only) SpectroChip CPM Kit (10x96) Calibrant CPM Dx MassARRAY Clean Resin 28g SpectroChip CPM Kit (2x96) registered
Roche Diagnostics Corp. Present in Europe in other categories United States cobas pro i 601 BL cobas i 601 SBL cobas i 601 registered
Agilent Technologies, Inc. Present in Europe in other categories United States K6460 Triple Quadrupole MS – ESI K6460 Triple Quadrupole MS – AJS registered
Perkinelmer Health Sciences Canada, Inc – QSight(tm) 210 Screening System registered
SERCON LIMITED United Kingdom Sercon registered
Wallac Oy Present in Europe in other categories Finland Qsight 225 MD Screening System registered
HITACHI HIGH-TECH CORP. Present in Europe in other categories Japan – registered
Labpeak Co.,Ltd China – registered
Revvity, Inc. Present in Europe in other categories United States – registered
Roche Diagnostics Operations Inc. United States – registered
Scitek Global Co.,Ltd China – registered
Thermo Fisher Scientific Present in Europe in other categories United States – registered

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