EUDAMED update: Mar 13, 2025

Hologic

US-MF-000001677

Active20 devices

Address: Campus Drive, 250 MA 01752 Marlborough
Role: Manufacturer
Date of registration: Feb 26, 2021
Country: United States

Hologic is a medical device manufacturer registered in EUDAMED. The company has 20 devices on the EU market across 31 countries. Headquartered in Marlborough, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Hologic Marlborough Cytology

: US-MF-000001677
Role: Manufacturer
Country: United States
Organization name: Hologic
EU VAT number: Not applicable
Date of registration: Feb 26, 2021

Contact details for Hologic Marlborough Cytology

Email: jeffrey.hergesheimer@hologic.com
Address: 250, CAMPUS DRIVE MA 01752 MARLBOROUGH UNITED STATES

Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Officers and regulatory representatives of Hologic Marlborough Cytology

HERGESHEIMER Jeffrey
Technical Documentation and EU DoC are drawn up and kept up to date For IVDR performance studies involving interventional devices or risks to subjects, ensure a signed statement by the person legally responsible for the manufacture of the device conforms to GSPR apart from the aspects covered by the clinical performance study and that for those aspects every precaution has been taken to protect the health and safety of the subject.
Hidden
LOOMER Wayne
- Conformity of devices is appropriately checked, in accordance with the QMS before a device is released - PMS obligations are complied with per MDR/IVDR - Reporting obligations with regard to PMS are fulfilled
Hidden

Connected operators

Importers

2 EU importers place this manufacturer's devices

Data export

Export the 20 devices of Hologic Marlborough Cytology

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Cellient Automated Cell Block System Filter Cassette Kit	Cellient Automated Cell Block System Filter Cassette Kit	`71305-001`	`15420045513938`	1	On the market
Cellient Automated Cell Block System Finishing Station	Cellient Automated Cell Block System Finishing Station	`71664-001`	`15420045508576`	1	On the market
Cellient Automated Cell Block System Processor	Cellient Automated Cell Block System Processor	`71959-001`	`15420045508569`	1	On the market
Compass Stainer	Compass Stainer	`ASY-05576`	`15420045513853`	1	On the market
PreservCyt Collection Medium	PreservCyt Collection Medium	`PRD-07138`	`15420045514812`	1	On the market
The ThinPrep Pap Test PreservCyt Solution	The ThinPrep Pap Test PreservCyt Solution	`ASY-05400`	`15420045508286`	1	On the market
The ThinPrep Pap Test PreservCyt Solution	The ThinPrep Pap Test PreservCyt Solution	`70097-003`	`15420045508255`	1	On the market
ThinPrep CytoLyt Solution	ThinPrep CytoLyt Solution	`0200012`	`15420045508453`	1	On the market
ThinPrep CytoLyt Solution	ThinPrep CytoLyt Solution	`0236041`	`15420045508446`	1	On the market
ThinPrep CytoLyt Solution	ThinPrep CytoLyt Solution	`70953-002`	`15420045508415`	1	On the market
ThinPrep PreservCyt Solution	ThinPrep PreservCyt Solution	`PRD-07132`	`15420045514782`	1	On the market
ThinPrep PreservCyt Solution	ThinPrep PreservCyt Solution	`70956-002`	`15420045508378`	1	On the market
ThinPrep Stain Bluing II Solution	ThinPrep Stain Bluing II Solution	`ASY-04876`	`15420045510166`	1	On the market
ThinPrep Stain Bluing Solution	ThinPrep Stain Bluing Solution	`70793-001`	`15420045509702`	1	On the market
ThinPrep Stain EA Solution	ThinPrep Stain EA Solution	`70782-002`	`15420045509719`	1	On the market
ThinPrep Stain Nuclear Stain	ThinPrep Stain Nuclear Stain	`70780-001`	`15420045509696`	1	On the market
ThinPrep Stain Orange G Solution	ThinPrep Stain Orange G Solution	`70781-002`	`15420045509658`	1	On the market
ThinPrep Stain Rinse II Solution	ThinPrep Stain Rinse II Solution	`ASY-04875`	`15420045510159`	1	On the market
ThinPrep Stain Rinse Solution	ThinPrep Stain Rinse Solution	`70779-001`	`15420045509689`	1	On the market
ThinPrep UroCyte PreservCyt Solution	ThinPrep UroCyte PreservCyt Solution	`ASY-15510`	`15420045514645`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Cellient Automated Cell Block System Filter Cassette Kit	Cellient Automated Cell Block System Filter Cassette Kit	`71305-001`	`15420045513938`	1	On the market
Cellient Automated Cell Block System Finishing Station	Cellient Automated Cell Block System Finishing Station	`71664-001`	`15420045508576`	1	On the market
Cellient Automated Cell Block System Processor	Cellient Automated Cell Block System Processor	`71959-001`	`15420045508569`	1	On the market
Compass Stainer	Compass Stainer	`ASY-05576`	`15420045513853`	1	On the market
PreservCyt Collection Medium	PreservCyt Collection Medium	`PRD-07138`	`15420045514812`	1	On the market
The ThinPrep Pap Test PreservCyt Solution	The ThinPrep Pap Test PreservCyt Solution	`ASY-05400`	`15420045508286`	1	On the market
The ThinPrep Pap Test PreservCyt Solution	The ThinPrep Pap Test PreservCyt Solution	`70097-003`	`15420045508255`	1	On the market
ThinPrep CytoLyt Solution	ThinPrep CytoLyt Solution	`0200012`	`15420045508453`	1	On the market
ThinPrep CytoLyt Solution	ThinPrep CytoLyt Solution	`0236041`	`15420045508446`	1	On the market
ThinPrep CytoLyt Solution	ThinPrep CytoLyt Solution	`70953-002`	`15420045508415`	1	On the market
ThinPrep PreservCyt Solution	ThinPrep PreservCyt Solution	`PRD-07132`	`15420045514782`	1	On the market
ThinPrep PreservCyt Solution	ThinPrep PreservCyt Solution	`70956-002`	`15420045508378`	1	On the market
ThinPrep Stain Bluing II Solution	ThinPrep Stain Bluing II Solution	`ASY-04876`	`15420045510166`	1	On the market
ThinPrep Stain Bluing Solution	ThinPrep Stain Bluing Solution	`70793-001`	`15420045509702`	1	On the market
ThinPrep Stain EA Solution	ThinPrep Stain EA Solution	`70782-002`	`15420045509719`	1	On the market
ThinPrep Stain Nuclear Stain	ThinPrep Stain Nuclear Stain	`70780-001`	`15420045509696`	1	On the market
ThinPrep Stain Orange G Solution	ThinPrep Stain Orange G Solution	`70781-002`	`15420045509658`	1	On the market
ThinPrep Stain Rinse II Solution	ThinPrep Stain Rinse II Solution	`ASY-04875`	`15420045510159`	1	On the market
ThinPrep Stain Rinse Solution	ThinPrep Stain Rinse Solution	`70779-001`	`15420045509689`	1	On the market
ThinPrep UroCyte PreservCyt Solution	ThinPrep UroCyte PreservCyt Solution	`ASY-15510`	`15420045514645`	1	On the market

Hologic

About Hologic Marlborough Cytology

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Importers

Export the 20 devices of Hologic Marlborough Cytology

Related searches

Market presence of Hologic Marlborough Cytology

Devices by risk class

Related documents

Certificate health for Hologic Marlborough Cytology

Statistics for Hologic Marlborough Cytology

Device families (Basic UDI-DI) of Hologic Marlborough Cytology

Device catalog for Hologic Marlborough Cytology