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TestCard Ltd

United Kingdom (ex Northern Ireland)·GB-MF-000013002

Last updated May 23, 2026

What TestCard Ltd makes

TestCard Ltd manufactures diagnostic test readers, including the Roche Combur-10 UX StripReader and the SureScreen Covid/Flu Test Reader. These devices are designed to analyze diagnostic test strips for clinical or point-of-care testing applications.

The company is based in Great Britain and its device portfolio is classified as Class A. These products are listed in the EUDAMED database in accordance with regulatory requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does TestCard Ltd manufacture?

TestCard Ltd specializes in diagnostic test readers, such as the Roche Combur-10 UX StripReader and the SureScreen Covid/Flu Test Reader. These devices are engineered to process and analyze diagnostic test strips for clinical or point-of-care testing, helping to automate and streamline results interpretation in healthcare settings.

Where is TestCard Ltd based?

TestCard Ltd is based in Great Britain. The company’s headquarters and operations are located within the UK, though specific regional offices or manufacturing sites are not detailed in the provided information.

Which regulatory registries list TestCard Ltd’s devices?

TestCard Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This inclusion ensures transparency and compliance with EU regulatory requirements for medical devices.

How are TestCard Ltd’s devices classified under medical device regulations?

TestCard Ltd’s devices fall under Class A classification, which is the lowest risk category in the EU’s medical device regulatory framework. This classification applies to devices posing minimal risk to patients and users, such as diagnostic test readers like those manufactured by the company.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United Kingdom (ex Northern Ireland)
Address
Unit 6 , Betton Business Park, Racecourse Road, Scarborough, United Kingdom (ex Northern Ireland)
Website
testcard.com
LinkedIn
—
Facebook
—
Phone
+447432582282
PRRC Contact
Marcus Gould
EUDAMED SRN
GB-MF-000013002
FDA FEI Number
—
DUNS Number
—

Catalogue (2)

DeviceModel / ReferenceRegistriesClassStatus
Roche Combur-10 UX StripReader C10R
EUDAMED
Class AActive
SureScreen Covid/Flu Test Reader SCFR
EUDAMED
Class AActive

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