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Emdyca

Instruments to support and monitor vital signsVital signs monitoring instrumentsGaseous exchange monitoring instruments

Carbon monoxide analysers

EMDN code Z1203020402

2 manufacturers, 3 models including 3 on the market, 1 country

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Manufacturers registered in Europe (EUDAMED) 2
  • 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
Bedfont FDA EU representative : Emergo Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) IIa MDR Website EUDAMED record Report an error
Mdd FDA EU representative : CS Life Sciences Europe Ltd (Ireland) United Kingdom (ex Northern Ireland) I MDR Website customercare@mdd.org.uk 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
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories China ORIDION CO2(Package/no accessory) 1-Slot CO2/O2 Module w/ kit (Neo) Sidestream CO2 module(FDA/FJ)II Sidestream CO2 module(FDA)II 1-Slot CO2 Module w/ kit (Neo) 115-046935-00 registered
Jaeger Medical GmbH Present in Europe in other categories Germany Vyaire Jaeger registered
Capnia, Inc. United States CoSense Precision Sampling Set CoSense ETCO Monitor CO Sensor Module K253119 (2026)
FIM MEDICAL Present in Europe in other categories France TABATABA V2 Pipette TRAPPER K080278 (2008)
CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC. – Pivot Breath Sensor registered
Vitalograph , Ltd. Present in Europe in other categories United States BreathCO K892524 (1989)
Carrot Sense, Inc. United States – K171408 (2017)
Carrot, Inc. United States – K201206 (2021)
Mossman Associates, Inc. United States – registered
Pivot Health Technologies Inc. United States – registered
Seacomp Displays Mexico – registered

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