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MIRION TECHNOLOGIES (CAPINTEC), INC

United States·US-MF-000000770

Last updated September 17, 2026

Information

Country: United States
Address: 7, Vreeland Road, Florham Park, United States
Website: www.capintec.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 001 201-825-9500
PRRC Contact: Mary Anne Yusko
EUDAMED SRN: US-MF-000000770
FDA FEI Number: 2518443
DUNS Number: —

Catalogue (39)

Device	Model / Reference	Registries	Class	Status
CII Transporter	0670-0007	FDA UDI	Class I	Unknown
AeroTech I Convenience Kit, Standard	177-124	FDA UDI	Class II	Active
Capintec Syringe Shield	1 cc Pin-Tec Syringe Shield	FDA UDI	Class I	Unknown
Venti-Scan IV Convenience Kit, 12 inch tubing	177-091	FDA UDI	Class II	Active
Capintec Syringe Shield	5 cc Pin-Tec Syringe Shield	FDA UDI	Class I	Unknown
Capintec Syringe Shield	3 cc C-Tec Syringe Shield	FDA UDI	Class I	Unknown
Capintec Syringe Shield	10 cc Pin-Tec Syringe Shield	FDA UDI	Class I	Unknown
Venti-Scan IV Convenience Kit, 24 inch tubing	177-092	FDA UDI	Class II	Active
Capintec Syringe Shield	1 cc C-Tec Syringe Shield	FDA UDI	Class I	Unknown
AeroTech I Convenience Kit, Venti Pak	177-325	FDA UDI	Class II	Active
MRI Stretcher	240-100	FDA UDI	Class II	Active
Capintec Syringe Shield	5 cc C-Tec Syringe Shield	FDA UDI	Class I	Unknown
CII Transporter II	0670-2026	FDA UDI	Class I	Unknown
Capintec Syringe Shield	10 cc C-Tec Syringe Shield	FDA UDI	Class I	Unknown
2 cc Pin-Tec Syringe Shield	4300-0060	FDA UDI	Class I	Unknown
Capintec Dose Calibrator	CRC-25W	FDA UDI	Class II	Active
Capintec Syringe Shield	511 C-Tec Syringe Shield, 10 cc	FDA UDI	Class I	Unknown
Capintec T-Vial Shield	T-Vial Shield	FDA UDI	Class I	Unknown
Capintec Syringe Shield	511 C-Tec Syringe Shield, 20 cc	FDA UDI	Class I	Unknown
Capintec Dose Calibrator	CRC-25R	FDA UDI	Class II	Active
Venti-Scan IV Shield	177-090	FDA UDI	Class II	Active
Venti-Scan IV Convenience Kit, Venti Pak	177-075	FDA UDI	Class II	Active
Capintec Dose Calibrator	CRC-25PET	FDA UDI	Class II	Active
AeroTech I Convenience Kit, Small Particle	177-324	FDA UDI	Class II	Active
AeroTech I Shield	177-095	FDA UDI	Class II	Active
Capintec Syringe Shield	511 C-Tec Syringe Shield, 5 cc	FDA UDI	Class I	Unknown
Capintec Syringe Shield	3 cc PIn-Tec Syringe Shield	FDA UDI	Class I	Unknown
MRI Stretcher with Fowler Positioning	240-110	FDA UDI	Class II	Active
Syringe Carrier, Single, 0.25"-0.5" Lead	009-205	EUDAMEDFDA UDI	Class I	Active
Vial Pig	001-706	EUDAMEDFDA UDI	Class I	Active
Bar Phantom, Cardiac, High Resolution	243-955	EUDAMED	Class I	Active
SHIELD, SYRINGE, 10cc, PRO-TEC IV	007-685	EUDAMEDFDA UDI	Class I	Active
Table, Pain Management C-Arm, 230VAC	058-875	EUDAMEDFDA UDI	Class I	Active
Table, Surgical C-Arm, Rectangle Top, 230 VAC	058-845-10	EUDAMEDFDA UDI	Class I	Active
SHIELD, SYRINGE, 5/6cc, DOSE DWG, NON-LUER	007-693	EUDAMEDFDA UDI	Class I	Active
CRC-77t	5130-30261	EUDAMEDFDA UDI	Class I	Active
Echo Pro Echocardiography Table	058-700	EUDAMEDFDA UDI	Class I	Active
SHIELD, SYRINGE, 3cc, LUER/NON-LUER	007-635	EUDAMEDFDA UDI	Class I	Active
Lead Vial Shield with Magnetic Cap	053-610	EUDAMEDFDA UDI	Class I	Active

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FDA Recalls (4)

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
Apr 22, 2024	Z-1893-2024	—	open, classified	Complaints of unexpected detachment of the collimator have been reported.
Apr 22, 2024	Z-1894-2024	—	open, classified	Complaints of unexpected detachment of the collimator have been reported.
Apr 22, 2024	Z-1892-2024	—	open, classified	Complaints of unexpected detachment of the collimator have been reported.
Nov 27, 2023	Z-1069-2024	—	open, classified	Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator