EU → North America Device Access

X-Tech Medical Ltd

GB-MF-000021768 · United Kingdom · Stonehouse

X-Tech Medical Ltd is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa32

Among these devices, 2 are declared sterile.

Authorised representative in the Union: Advena Limited.

Catalogue references include HGI-1824A, ISC100-1215A, PBC-1215A, PBC-1215S, PBC-2632A, SCB-S1H4.

European nomenclature codes declared: V070101, V9099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryX-TECH MEDICAL LTD (GB) · FDA 3011307916
Devices in EUDAMED32
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN32
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryX-TECH MEDICAL

North American profile: Both markets. X-Tech Medical Ltd is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
GB25/000009issued2030-01-14
GB25/0000009issued2030-01-14

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