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Hologic Inc.

United States·US-MF-000001646

Last updated September 17, 2026

Information

Country: United States
Address: 250 , Campus Drive, Marlborough, United States
Website: hologic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Marissa Richmond
EUDAMED SRN: US-MF-000001646
FDA FEI Number: 3005496266
DUNS Number: —

Catalogue (53)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Brevera Needle Guide	BREV-NG07R	EUDAMED	Class IIa	Active
Brevera Breast Biopsy System Tissue Filter Base	BREVTFB	EUDAMED	Class IIa	Active
Aptima Transfer Solution	303658	EUDAMED	Class A	Active
Brevera Breast Biopsy System Standard Stereotactic Biopsy Needle	BREVDISP07	EUDAMED	Class IIa	Active
Brevera Needle Guide	BREV-NG07L	EUDAMED	Class IIa	Active
Fluent Pro Fluid Management System Procedure Kit	FLT-212S	EUDAMEDFDA UDI	Class IIa	Active
Aptima HPV Assay Calibrators Kit	302554	EUDAMED	Class C	Active
Panther Fusion AdV/hMPV/RV Assay Controls Kit	PRD-04338	EUDAMEDFDA UDI	Class B	Active
ATEC Breast Biopsy and Excision System Ultrasound Introducer	AI121220	EUDAMEDFDA UDI	Class IIa	Active
ATEC Breast Biopsy and Excision System Handpiece	ATEC 1212-20	EUDAMEDFDA UDI	Class IIa	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_0910-12T	EUDAMEDFDA UDI	Class IIa	Active
ATEC MRI Breast Biopsy and Excision System Handpiece	ATEC 0914-12MR	EUDAMEDFDA UDI	Class IIa	Active
MyoSure Single Use Seal	40-902	EUDAMEDFDA UDI	Class I	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_0910-20	EUDAMEDFDA UDI	Class IIa	Active
ATEC Breast Biopsy and Excision System Handpiece	ATEC 0912-12	EUDAMEDFDA UDI	Class IIa	Active
ATEC Breast Biopsy and Excision System Introducer Localization System	ILS 0914-12	EUDAMEDFDA UDI	Class IIa	Active
ATEC Breast Biopsy and Excision System Ultrasound Introducer	AI091220	EUDAMEDFDA UDI	Class IIa	Active
Aptima Trichomonas vaginalis Controls Kit	302807	EUDAMEDFDA UDI	Class C	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_0913-12T	EUDAMEDFDA UDI	Class IIa	Active
Aptima Mycoplasma genitalium Assay Calibrators Kit	PRD-03393	EUDAMEDFDA UDI	Class C	Active
Omni 5 Fr. Seal Cap	60-5FR	EUDAMEDFDA UDI	Class I	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_0910-12	EUDAMEDFDA UDI	Class IIa	Active
NovaSure Impedance Controlled Endometrial Ablation System V5 Disposable Device	NSV5-001	EUDAMED	Class IIb	Active
ATEC Breast Biopsy and Excision System Ultrasound Introducer	AI090920	EUDAMEDFDA UDI	Class IIa	Active
MyoSure LITE Tissue Removal Device	30-401LITE	EUDAMEDFDA UDI	Class IIa	Active
Panther Fusion AdV/hMPV/RV Assay	PRD-04330	EUDAMEDFDA UDI	Class B	Active
Aptima Trichomonas vaginalis Assay	303163	EUDAMEDFDA 510(k)	Class C	Active
MyoSure REACH Tissue Removal Device	10-401FC	EUDAMEDFDA UDI	Class IIa	Active
NovaSure Impedance Controlled Endometrial Ablation System Advanced Disposable Device	NS2013	EUDAMED	Class IIb	Active
Fluent Fluid Management System Waste Bag	FLT-005	EUDAMEDFDA UDI	Class I	Active
ATEC MRI Breast Biopsy and Excision System Handpiece	ATEC 0914-20MR	EUDAMEDFDA UDI	Class IIa	Active
ATEC Breast Biopsy and Excision System Ultrasound Introducer	AI120920	EUDAMEDFDA UDI	Class IIa	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_0913-12	EUDAMEDFDA UDI	Class IIa	Active
ATEC Breast Biopsy and Excision System Handpiece	ATEC 0914-20	EUDAMEDFDA UDI	Class IIa	Active
ATEC Breast Biopsy and Excision System Introducer Localization System	ILS 0914-20	EUDAMEDFDA UDI	Class IIa	Active
NovaSure Impedance Controlled Endometrial Ablation System RF Controller Model 10	RFC2010	EUDAMED	Class IIb	Active
ATEC Breast Biopsy and Excision System Handpiece	ATEC 0909-12	EUDAMEDFDA UDI	Class IIa	Active
Fluent Pro Fluid Management System Waste Bag	FLT-205	EUDAMEDFDA UDI	Class I	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_1210-20	EUDAMEDFDA UDI	Class IIa	Active
Fluent Fluid Management System	FLT-100	EUDAMEDFDA UDI	Class IIb	Active
Panther Fusion MRSA Assay Controls	PRD-04805	EUDAMED	Class C	Active
MyoSure Control Unit	10-550	EUDAMEDFDA UDI	Class IIb	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_0913-20	EUDAMEDFDA UDI	Class IIa	Active
Fluent Pro Fluid Management System Tissue Trap	FLT-210	EUDAMEDFDA UDI	Class I	Active
Panther Fusion MRSA Assay	PRD-04803	EUDAMED	Class C	Active
Omni Lok Cervical Seal	OLK-100	EUDAMEDFDA UDI	Class I	Active
Eviva Stereotactic Guided Breast Biopsy System Biopsy Device	EVIVA_1213-20	EUDAMEDFDA UDI	Class IIa	Active
MyoSure MANUAL Tissue Removal Device	20-401ML	EUDAMEDFDA UDI	Class IIa	Active
Aptima Neisseria gonorrhoeae	302927	EUDAMEDFDA UDI	Class C	Active
Fluent Pro Fluid Management System	FLT-200	EUDAMEDFDA UDI	Class IIb	Active

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