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Emdyca

Chemistry / immunochemistry instrumentsChemistry / immunochemistry rapid tests + POC testsVarious rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)

Various rapid test chemistry / immunochemistry instruments - consumables

EMDN code W0201069085

6 manufacturers, 10 models including 10 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 6
  • 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
Sentinel FDA Italy A IVDR Website EUDAMED record Report an error
MicroBioSensor EU representative : QNET B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 Website enquiries@microbiosensor.com EUDAMED record Report an error
NIOX Sweden B IVDR qa@niox.com EUDAMED record Report an error
PAL Finland Finland – 98/79 Website EUDAMED record Report an error
PHC FDA EU representative : PHC Europe B.V. (Netherlands) Japan A IVDR EUDAMED record Report an error
Poclight EU representative : HUMISS TRADING S. L. (Spain) China A IVDR info@poclight.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) 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
Circassia AB United States NIOX K170983 (2017)
Caire Diagnostics Inc. Present in Europe in other categories United States CAIRE Diagnostics K213611 (2023)
Bosch Healthcare Solutions GmbH Present in Europe in other categories Germany Vivatmo pro Oxycap Vivatmo pro Level 0 Spare part: Vivatmo pro handheld US Vivatmo pro Spare part: Vivatmo pro base station US K243926 (2025)
Bedfont Scientific, Ltd. Present in Europe in other categories United Kingdom NObreath® FeNOBreath NOBreath K203695 (2021)
Medical Graphics Corp. Present in Europe in other categories United States Fenom Flo™ registered
Emsere, Inc Netherlands – registered
LRE MEDICAL GMBH Germany – registered
Medi Soft SA Belgium – registered
Mgc Diagnostics Corporation United States – K251674 (2025)
Sanner GmbH Germany – registered
Spirosure, Inc. United States – K182874 (2019)

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