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Sol-Millennium Medical, Inc.

United States·US-MF-000010890

Last updated September 17, 2026

Information

Country: United States
Address: 311 S Wacker Drive, Suite 4100, Chicago, United States
Website: sol-m.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Yajaira Orozco
EUDAMED SRN: US-MF-000010890
FDA FEI Number: 3014312726
DUNS Number: —

Catalogue (489)

Page 1 of 10

Device	Model / Reference	Registries	Class	Status
Vacumed Safety Multi Sample Needle with Pre-Attached Holder	45414	EUDAMED	Class IIa	Active
SOL-GUARD Safety Pull-button IV Infusion Set	PBIV25012	EUDAMED	Class IIa	Active
SOL-GUARD Safety Pull-button IV Infusion Set	PBIV21012	EUDAMED	Class IIa	Active
SOL-GUARD Safety Pull-button IV Infusion Set	PBIV2107	EUDAMED	Class IIa	Active
SOL-GUARD Safety Pull-button IV Infusion Set	PBIV23012	EUDAMED	Class IIa	Active
SOL-GUARD Safety Pull-button IV Infusion Set	PBIV2507	EUDAMED	Class IIa	Active
SOL-CARE Safety Winged Infusion Set	193407SI	EUDAMED	Class IIa	Active
SOL-CARE Safety Winged Infusion Set	S213407SI	EUDAMED	Class IIa	Active
SOL-GUARD Safety Pull-button IV Infusion Set	PBIV2307	EUDAMED	Class IIa	Active
SOL-CARE Safety Winged Infusion Set	S223412SI	EUDAMED	Class IIa	Active
SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle	K242291	FDA 510(k)	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	1633012	FDA UDI	Class II	Active
SOL-CARE™ Insulin Syringe w/Fixed Needle	100091IM	FDA UDI	Class II	Active
SOL-M™ Luer Lock Syringe without Needle	180030	FDA UDI	Class II	Active
SOL-M™ Multi-Sample Needle	110201020005	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	110102010039	FDA UDI	Class II	Active
SOL-M Insulin Syringe	1612812B	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN2310	FDA UDI	Class II	Active
SOL-M 10ml Luer Lock Syringe Sterile Convenience Tray	P180010TU	FDA UDI	Class II	Active
SOL-M™ Luer Lock Syringe with Exchangeable Needle	110101120012	FDA UDI	Class II	Active
SOL-M™ Luer Lock Syringe without Needle	180005	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe w/Safety Needle	12705SN	FDA UDI	Class II	Active
SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder	110201030006	EUDAMEDFDA UDI	Class II	Active
SOL-CARE™ Safety Blood Collection Needle	110201030009	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	1653012B	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	52010SN	FDA UDI	Class II	Active
SOL-M™ Allergy Syringe Tray	181026IDBT	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN2510	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe w/Safety Needle	52210SN	FDA UDI	Class II	Active
SOL-M™ Luer Lock Syringe without Needle	180001PP	FDA UDI	Class II	Active
SOL-M 10ml Luer Lock Syringe Only (bulk, sterile)	C180010BS	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	32215SN	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	1633151B	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	110102010044	FDA UDI	Class II	Active
SOL-CARE™ Safety Needle	SN2512	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	32110SN	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	32115SN	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN3012	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	32015SN	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe w/Safety Needle	102210SN	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN2215	FDA UDI	Class II	Active
SOL-CARE Safety Needle	PSN2110	FDA UDI	Class II	Active
SOL-M™ U-100 Insulin Syringe with Fixed Needle	16130516	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	32210SN	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe with Safety Needle	52115SN	FDA UDI	Class II	Active
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1	32210SN	FDA UDI	Class II	Active
SOL-CARE™ Luer Lock Syringe w/Safety Needle	13005SN	FDA UDI	Class II	Active
SOL-M™ Multi-Sample Needle	110201020009	FDA UDI	Class II	Active
SOL-M™ Syringe w/Fixed Needle (Low Dead Space)	110401010001	FDA UDI	Class II	Active
SOL-CARE Safety Needle 25G*1 1/2 "(Bulk, Non-sterile)	SN2515B	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Sol-Millennium Europe Sp. z o.o. PL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 9, 2024	Z-3077-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3079-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3075-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3074-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3076-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
May 9, 2024	Z-3078-2024	—	open, classified	Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.