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Unomedical A/S

Last updated May 24, 2026

What Unomedical A/S makes

The company manufactures single-use electric infusion pump administration sets designed for automated delivery of fluids, including insulin and other medications, as well as subcutaneous infusion or injection ports with needles for continuous or intermittent use. These devices are intended for medical settings and home use, supporting precise dosing and patient convenience in conditions requiring long-term infusion therapy.

The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) premarket notification process and listed in the FDA’s Unique Device Identifier (UDI) database. The company’s products are based in the United States, adhering to U.S. regulatory standards for infusion systems and subcutaneous access devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 9999999999
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 306032491

Catalogue (622)

Page 13 of 13

Device	Model / Reference	Registries	Class	Status
Accu-Chek TenderLink™	04541634001	FDA UDI	Class II	Unknown
MiniMed™ Mio™ Advance	MMT-242AT	FDA UDI	Class II	Active
Minimed™ Mio™	MMT-975A	FDA UDI	Class II	Active
inset™	FG000016-06	FDA UDI	Class II	Active
Autosoft90™	1002821	FDA UDI	Class II	Active
neria™ detach	78-080-2728	FDA UDI	Class II	Unknown
Comfort Short™	004173	FDA UDI	Class II	Unknown
Varisoft™	1000285	FDA UDI	Class II	Unknown
neria™	78-080-2738	FDA UDI	Class II	Unknown
Click-On	K040633	FDA 510(k)	Class II	Active
Medtronic Extended infusion set	K210544	FDA 510(k)	Class II	Active
Comfort And Inset Subcutaneous Infusion Sets For Use With Abbott Infusion Pumps	K051264	FDA 510(k)	Class II	Active
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	K160648	FDA 510(k)	Class II	Active
Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set	K162812	FDA 510(k)	Class II	Active
Contact Detach	K041545	FDA 510(k)	Class II	Active
Unomedical Monica Infusion Set	K032854	FDA 510(k)	Class II	Active
neria guard Infusion Set	K192647	FDA 510(k)	Class II	Active
MiniMed Mio Advance infusion set	K173879	FDA 510(k)	Class II	Active
Neria Soft 90 Infusion Set	K132142	FDA 510(k)	Class II	Active
Intuition Infusion Sets	K061374	FDA 510(k)	Class II	Active
I-Port Advance Injection Port	K120337	FDA 510(k)	Class II	Active
Paradigm Quick-Set Ii And Quick-Set Ii Subcutaneous Infusion Sets	K070430	FDA 510(k)	Class II	Active

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