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
Sterilization/disinfection container reusableSterilization/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
Hysteroscopic irrigation/insufflation systemHysteroscopic irrigation/insufflation systemClass IIa
Imaging lesion localization marker implantableImaging lesion localization marker implantableClass IIb
Soft-tissue biopsy procedure kit non-medicatedSoft-tissue biopsy procedure kit non-medicatedClass IIa
Tissue morcellation systemTissue morcellation systemClass IIa
Tissue morcellation system handpiece line-poweredTissue morcellation system handpiece line-poweredClass IIa
Mammographic stereotactic biopsy systemMammographic stereotactic biopsy systemClass I
Mammographic stereotactic biopsy systemMammographic stereotactic biopsy systemClass IIa
Rigid optical hysteroscopeRigid optical hysteroscopeClass IIa
Microscope slide digital imaging scanner IVDMicroscope slide digital imaging scanner IVDIVD General
Rigid optical hysteroscopeRigid optical hysteroscopeClass I
Tissue morcellation systemTissue morcellation systemClass IIa
Hysteroscopic irrigation/insufflation systemHysteroscopic irrigation/insufflation systemClass IIb
Basic light microscopeBasic light microscopeClass I
Mammographic stereotactic biopsy systemMammographic stereotactic biopsy systemClass IIa
Cytology fixative solution IVDCytology fixative solution IVDIVD General
Tissue processor IVD automated/semi-automatedTissue processor IVD automated/semi-automatedIVD General
General tissue specimen container IVD fixative/salineGeneral tissue specimen container IVD fixative/salineIVD General
Microscope slide stainer IVDMicroscope slide stainer IVDIVD General
Surgical suction system collection container single-useSurgical suction system collection container single-useClass I
Mammographic stereotactic biopsy systemMammographic stereotactic biopsy systemClass I
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Hysteroscopic irrigation/insufflation systemHysteroscopic irrigation/insufflation systemClass I
Soft-tissue biopsy procedure kit non-medicatedSoft-tissue biopsy procedure kit non-medicatedClass I
Soft-tissue biopsy procedure kit non-medicatedSoft-tissue biopsy procedure kit non-medicatedClass I
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumIVD General
Cytology specimen container IVD transport bufferCytology specimen container IVD transport bufferIVD General
Laboratory instrument/analyser application software IVDLaboratory instrument/analyser application software IVDIVD General
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 IIb
Radio-frequency endometrial-ablation system handpiece/electrodeRadio-frequency endometrial-ablation system handpiece/electrodeClass IIb