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Emdyca

General medicine instrumentsGeneral medicine therapeutic treatment instrumentsPortable microinfusion instruments

Portable insulin infusion instruments

EMDN code Z1204021601

11 manufacturers, 78 models including 46 on the market, 7 countries

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Manufacturers registered in Europe (EUDAMED) 11
  • 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
Insulet FDA EU representative : Insulet Netherlands B.V. (Netherlands) United States
22 others
 IIb, III MDR, 93/42 Website EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands) United States
2 others
 IIb, III MDR, 93/42 EUDAMED record Report an error
Medtrum EU representative : Medtrum B.V. (Netherlands) China
9 others
 IIb MDR, 93/42 info@medtrum.com EUDAMED record Report an error
Roche FDA Germany IIb 93/42 Website EUDAMED record Report an error
Tandemdiabetes FDA EU representative : MDSS GmbH (Germany) United States III MDR EUDAMED record Report an error
B.C.Trade Italy IIb MDR EUDAMED record Report an error
G2E EU representative : Advena SRL (Italy) South Korea IIb MDR Website EUDAMED record Report an error
MicroTech Medical (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) China IIb 93/42 Website EUDAMED record Report an error
mylife Diabetes Care EU representative : mylife Distribution GmbH (Germany) Switzerland IIb MDR regulatory-affairs@mylife-diabetescare.com EUDAMED record Report an error
Terumo FDA EU representative : TERUMO EUROPE N.V. (Belgium) Japan IIb 93/42 Eudamed_LAA@terumo.co.jp EUDAMED record Report an error
Ypsomed FDA EU representative : Ypsomed Produktion GmbH (Germany) No model still on the market Switzerland
16 others
 IIa, IIb 93/42 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) 9

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)
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
Sanmina Corporation United States – registered
Triple Jump Israel , Ltd. Israel – K230545 (2023)

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