Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Hologic Inc.

Address:

36 Apple Ridge Road

Danbury

Connecticut 6810

United States

Serilization:

Authorised Representative
Name: Hologic Ltd.
Address:

Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester

Lancashire M23 9HZ

England United Kingdom

Code/Term Type

Specimen x-ray system IVD Class I

Radiology PACS software Class I

Radiology DICOM image processing application software Class I

Stationary mammographic x-ray system, digital Class IIb

Mammographic stereotactic biopsy system Class IIb

Bone absorptiometric x-ray system, dual-energy Class IIb

Mobile general-purpose fluoroscopic x-ray system, digital Class IIb

Radiological breast positioner, non-wearable Class IIa

Radiological breast positioner, non-wearable Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Specimen x-ray system IVD		Class I
Radiology PACS software		Class I
Radiology DICOM image processing application software		Class I
Stationary mammographic x-ray system, digital		Class IIb
Mammographic stereotactic biopsy system		Class IIb
Bone absorptiometric x-ray system, dual-energy		Class IIb
Mobile general-purpose fluoroscopic x-ray system, digital		Class IIb
Radiological breast positioner, non-wearable		Class IIa
Radiological breast positioner, non-wearable		Class I