United Kingdom MHRA device registration 200921

Stationary mammographic x-ray system, digital

United Kingdom·General Medical Device·Hologic, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 200921
MHRA Reference Number: 200921
Date Registered: Nov 26, 2024
Last Updated: Aug 15, 2024

Device classification

Device Type: General Medical Device
Devices: Stationary mammographic x-ray system, digital
Type: Class I

Manufacturer

Name: Hologic, Inc.
Address: 600 Technology Drive
Newark, Delaware, United States
Created Date: Apr 4, 2019

Authorized Representative

Name: Hologic Ltd.
Relationship Type: UK Responsible Person
Address: Heron House 6 The Oaks Business Park Crewe Road Wythenshawe
Manchester, Lancashire, England, United Kingdom
Postcode: M23 9HZ

Similar products

Devices with a matching generic name or device type registered with MHRA

Bedside information system application softwareN/A

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Device ID: 150617

Orthopaedic implant aiming/guiding block, reusableN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127346

Arthroplasty force sensorN/A

Type: General Medical Device

Manufacturer: Orthosensor, Inc.

Device ID: 168000

Cervicothoracolumbosacral spine orthosis, rigidN/A

Type: General Medical Device

Manufacturer: Ossur hf.

Device ID: 129632

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobialN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127370

Orthopaedic fixation plate, non-bioabsorbable, non-sterileN/A

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 78945

Radiology PACS softwareN/A

Type: General Medical Device

Manufacturer: Optos Plc

Device ID: 39225

Scanning-laser ophthalmic imaging systemN/A

Type: General Medical Device

Manufacturer: Optos Plc

Device ID: 29433

Dental implant abutment trialN/A

Type: General Medical Device

Manufacturer: OsteoCare Implant System Ltd

Device ID: 131988

Physiologic monitoring system alarmN/A

Type: General Medical Device

Manufacturer: GE Medical Systems Information Technologies, Inc.

Device ID: 150616

Other products from Hologic, Inc.

Additional devices registered by the same manufacturer

Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)Mar 6, 2025

Type: In Vitro Diagnostic Device

Device ID: 212402

Mammographic stereotactic biopsy systemJan 7, 2025

Type: General Medical Device

Device ID: 208059

Buffered sample diluent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 184976

Cytomegalovirus (CMV) nucleic acid IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 86492

Cytomegalovirus (CMV) nucleic acid IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 194421

Exogenous DNA/RNA internal control IVD, kitNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 147651

General specimen collection kit IVD, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 184985

Fibronectin IVD, kit, enzyme immunohistochemistryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 184973

General specimen collection kit IVD, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 85941

Buffered sample diluent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 184977

Other products from same authorized representative

Additional devices represented by Hologic Ltd. in the UK

Cytomegalovirus (CMV) nucleic acid IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 86498

Cytomegalovirus (CMV) nucleic acid IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 194420

Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 194422

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 194418

Beta-haemolytic Group B Streptococcus nucleic acid IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 111374

Beta-haemolytic Group B Streptococcus nucleic acid IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 184967

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 111373

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 184966

Buffered sample diluent IVD, automated/semi-automated systemNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 46161

Fibronectin IVD, kit, enzyme immunohistochemistryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Hologic, Inc.

Device ID: 111920

About this record

Stationary mammographic x-ray system, digital is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 200921. The device is manufactured by Hologic, Inc. from United States, classified as General Medical Device. The authorized representative in the UK is Hologic Ltd..

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free DatabasePowered by Pure Global AIMHRA RegisteredGeneral Medical Device