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Emdyca

Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsInfusion instruments

Infusion instruments - software accessories

EMDN code Z12030382

10 manufacturers, 13 models including 13 on the market, 5 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
Bbraun FDA Germany IIb MDR Website eudamed@bbraun.com EUDAMED record Report an error
Bd FDA EU representative : Becton Dickinson Ireland Limited (Ireland) Switzerland IIb MDR Website EUDAMEDenquiries@bd.com EUDAMED record Report an error
Fresenius Kabi FDA Germany I, IIb MDR Website EUDAMED-FK@fresenius-kabi.com EUDAMED record Report an error
Axium MTech EU representative : Cedic srl (Italy) Switzerland I MDR quality@axium-mtech.com EUDAMED record Report an error
Baxter FDA EU representative : Baxter Deutschland GmbH (Germany) Switzerland IIb MDR Website EUDAMED record Report an error
Medtrum EU representative : Medtrum B.V. (Netherlands) China IIb 93/42 info@medtrum.com EUDAMED record Report an error
MicroTech Medical (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) China I MDR Website EUDAMED record Report an error
Sino Medical-Device Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb 93/42 EUDAMED record Report an error
Tandemdiabetes FDA EU representative : MDSS GmbH (Germany) United States III MDR EUDAMED record Report an error
Terumo FDA EU representative : TERUMO EUROPE N.V. (Belgium) Japan I MDR Eudamed_LAA@terumo.co.jp 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
Beta Bionics, Inc. United States iLet Bionic Pancreas iLet Insulin Infusion Kit iLet Connect Adapter 15-Pack (BB3052) iLet Starter Kit - Inset 23" iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack iLet Connect Adapter K263422 (2026)
Insulet Corporation Present in Europe in other categories United States Omnipod 5 Pod Omnipod 5 Controller APP Omnipod 5 Starter Kit Omnipod 5 Controller K231826 (2023)
Medtronic Minimed Present in Europe in other categories United States MiniMed Flex MiniMed 780G Insulin Pump K253743 (2026)
Medtronic, Inc. Present in Europe in other categories United States MiniMed Extended Supply Kit MiniMed Flex Starter Kit registered
Deka Research and Development United States – K261672 (2026)
Embecta Medical I, LLC United States – K234027 (2024)
Flextronics International USA, Inc. United States – registered
Jabil Inc. United States – registered
Merrimack Manufacturing United States – registered
Millyard Advanced Medical Products LLC United States – registered
Roche Diabetes Care GmbH Present in Europe in other categories Germany – K213134 (2023)
Sanmina Corporation United States – registered
Triple Jump Israel , Ltd. Israel – K230545 (2023)

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