Manufacturer

Insulet

United StatesLegal entities : Insulet Corporation

Markets : Austria · Belgium · Croatia · Denmark · Finland · France · Germany · Greece · Italy · Netherlands · Norway · Spain · Sweden · United States

Approvals : EU – class IIa, IIb, III · United States (FDA) – 510(k) : 25 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 2 · Spain 2

EU representative : Insulet Netherlands B.V. (Netherlands)

Website

5 categories, 30 models including 30 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Portable insulin microinfusors	Z120402160101	Omnipod Insulin Management System2 refs93/42 Omnipod Insulin Management System 18900-5D93/42 Omnipod Insulin Management System 18900-5E93/42 Omnipod Insulin Management System 18900-5F93/42 Omnipod Insulin Management System 18900-5K93/42 12 others Omnipod Insulin Management System 18900-5M93/42 Omnipod Insulin Management System 18900-5N93/42 Omnipod Insulin Management System 18900-5S93/42 Omnipod Insulin Management System 18900-5T93/42 Omnipod Insulin Management System 18900-6F93/42 Omnipod Insulin Management System 18900-6G93/42 Omnipod Insulin Management System 18900-6L93/42 Omnipod Insulin Management System 18900-9H93/42 Omnipod Insulin Management System 18916-6G93/42 Omnipod Insulin Management System 18916-6L93/42 Omnipod Insulin Management System 1919193/42 Omnipod Insulin Management System Part No. 18916-6F, SKT-DET45693/42	IIb 93/42	EUDAMED record Report an error
Portable insulin microinfusors with handheld glucose meter	Z120402160102	Omnipod Insulin Management System 18916-5D93/42 Omnipod Insulin Management System 18916-5E93/42 Omnipod Insulin Management System 18916-5F93/42 Omnipod Insulin Management System 18916-5K93/42 Omnipod Insulin Management System 18916-5M93/42 4 others Omnipod Insulin Management System 18916-5N93/42 Omnipod Insulin Management System 18916-5S93/42 Omnipod Insulin Management System 18916-5T93/42 Omnipod Insulin Management System 18916-9H93/42	IIb 93/42	EUDAMED record Report an error
Portable insulin microinfusors connectable to continuous glucose monitoring systems	Z120402160103	Omnipod 5 Automated Insulin Delivery System3 refs Omnipod Insulin Management System93/42	IIb, III MDR, 93/42	EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - software accessories	Z12040182	Omnipod Discover	IIa MDR	EUDAMED record Report an error
Portable microinfusion instruments - other	Z1204021699	Ferring Drug Delivery System93/42	IIb 93/42	EUDAMED record Report an error

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