General medicine therapeutic treatment instrumentsPortable microinfusion instrumentsPortable insulin infusion instruments
Portable insulin microinfusors connectable to continuous glucose monitoring systems
EMDN code Z120402160103
Manufacturers registered in Europe (EUDAMED) 4
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Medtronic FDA EU representative : Medtronic B.V. (Netherlands) | United States |
2 others
|
IIb, III MDR, 93/42 | EUDAMED record Report an error |
| Insulet FDA EU representative : Insulet Netherlands B.V. (Netherlands) | United States | IIb, III MDR, 93/42 | Website EUDAMED record Report an error | |
| Tandemdiabetes FDA EU representative : MDSS GmbH (Germany) | United States | III MDR | EUDAMED record Report an error | |
| Medtrum EU representative : Medtrum B.V. (Netherlands) No model still on the market | China |
|
IIb 93/42 | info@medtrum.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) 10
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.
| Manufacturer | Country | Brands | FDA 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 |
| 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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