Manufacturer's Devices - Hologic Inc.

Address:




250 Campus Drive



Marlborough

MA 1752

United States


Authorised Representative/ UK Responsible Person
Name: Hologic Ltd.
Address:

Heron House 6 The Oaks Business Park Crewe Road Wythenshawe



Manchester

Lancashire M23 9HZ

England United Kingdom




Code/Term Type
Imaging lesion localization marker implantableImaging lesion localization marker implantableClass III
Device sterilization/disinfection container reusableDevice sterilization/disinfection container reusableClass I
Hysteroscopic irrigation/insufflation systemHysteroscopic irrigation/insufflation systemClass I
Mammographic stereotactic biopsy systemMammographic stereotactic biopsy systemClass I
Hysteroscopy cervical leakage sheathHysteroscopy cervical leakage sheathClass I
Soft-tissue biopsy procedure kit non-medicatedSoft-tissue biopsy procedure kit non-medicatedClass IIa
Tissue morcellation systemTissue morcellation systemClass IIb
Tissue morcellation system handpiece line-poweredTissue morcellation system handpiece line-poweredClass IIa
Rigid optical hysteroscopeRigid optical hysteroscopeClass IIa
Microscope slide digital imaging scanner IVDMicroscope slide digital imaging scanner IVDClass IIa
Basic light microscopeBasic light microscopeClass I
Cytology fixative solution IVDCytology fixative solution IVDClass IIa
Tissue processor IVD automated/semi-automatedTissue processor IVD automated/semi-automatedClass IIa
General tissue specimen container IVD fixative/salineGeneral tissue specimen container IVD fixative/salineIVD General
Microscope slide stainer IVDMicroscope slide stainer IVDClass I
Surgical suction system collection container single-useSurgical suction system collection container single-useClass IIa
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumClass IIb
Cytology specimen container IVD transport bufferCytology specimen container IVD transport bufferClass I
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDClass IIa
Microscope slide maker IVDMicroscope slide maker IVDIVD General
Cervical cytology microscopy slide IVDCervical cytology microscopy slide IVDIVD General
Non-evacuated urine specimen container IVD no additiveNon-evacuated urine specimen container IVD no additiveIVD General
Biological stain IVDBiological stain IVDIVD General
Radio-frequency endometrial-ablation system generatorRadio-frequency endometrial-ablation system generatorClass I
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass I
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass I
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass I
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass I
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass I
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeIVD General
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeIVD General
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeIVD General
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeIVD General
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeIVD General
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeIVD General
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeIVD General
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass IIb
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass IIb