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
Radio-frequency ablation systemRadio-frequency ablation systemClass 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
Radio-frequency ablation systemRadio-frequency ablation systemClass IIb
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
Biological stain IVDBiological stain IVDIVD General
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 salineGeneral tissue specimen container IVD 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