EU → North America Device Access

Perspectum Ltd

GB-MF-000016685 · United Kingdom · Oxford

Perspectum Ltd is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa4
Class IIb1

Most frequent device types declared: Hepatica v1, LiverMultiScan v5, v1.01, v6.1.

Among these devices, 4 are declared active, 4 with a measuring function.

Authorised representative in the Union: Perspectum Unipessoal Lda.

Devices declared under this manufacturer

Catalogue references include 1.01, LiverMultiScan v5, NA, v1.

European nomenclature codes declared: Z11059082.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPERSPECTUM LTD. (GB) · FDA 3014232555
Devices in EUDAMED5
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN1
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Perspectum Ltd is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
SCAR-22.2.1.1restricted2029-05-21

Other manufacturers in United Kingdom

All United Kingdom manufacturers →