EUDAMED update: Jun 17, 2026

ExamenLab Ltd.

XI-MF-000013013

Active2 devices

Address: Weavers Business Park, Unit 10G BT12 5GH Belfast
Role: Manufacturer
Date of registration: Sep 10, 2021
Country: XI

ExamenLab Ltd. is a medical device manufacturer registered in EUDAMED. The company has 2 devices on the EU market across 1 country. Explore the regulatory profile, devices and certificates on MD Atlas.

About Examen

: XI-MF-000013013
Role: Manufacturer
Country: XI
Organization name: ExamenLab Ltd.
EU VAT number: Not applicable
EORI: 075542405000
Date of registration: Sep 10, 2021

Contact details for Examen

Phone: +44 2 890 23 89 15
Email: contact@examenlab.com
Website: www.examenlab.com
Address: UNIT 10G, WEAVERS BUSINESS PARK LINFIELD ROAD BT12 5GH BELFAST XI

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Competent authority

Name: The Medicines and Healthcare Products Regulatory Agency

Phone: +44 203 080 7080
Email: aic@mhra.gov.uk

Officers and regulatory representatives of Examen

LAWLOR Marty
Conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before release. The technical documentation and the EU DofC are drawn up and kept up-to-date. The PMS obligations are complied with in accordance with Article 10(9). The reporting obligations referred to in Articles 82 to 86 are fulfilled. In the case of devices for performance studies the statement referred to in Section 4.1 of Annex XIV is issued.
Hidden

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
Exact	Exact	`1001`	`D-100198`	1	On the market
Extend	Extend	`1002`	`D-10029A`	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
Exact	Exact	`1001`	`D-100198`	1	On the market
Extend	Extend	`1002`	`D-10029A`	1	On the market

ExamenLab Ltd.

About Examen

Contact details for Examen

Export the 2 devices of Examen

Competent authority

Officers and regulatory representatives of Examen

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About Examen

Contact details for Examen

Export the 2 devices of Examen

Competent authority

Officers and regulatory representatives of Examen

Statistics for Examen

Certificate health for Examen

Devices by risk class

Market presence of Examen

Device catalog for Examen

Device families (Basic UDI-DI) of Examen

Related searches

Market presence of Examen

Devices by risk class

Certificate health for Examen

Statistics for Examen

Device families (Basic UDI-DI) of Examen

Device catalog for Examen