EU → North America Device Access

Medasil Surgical Limited

GB-MF-000009549 · United Kingdom · Leeds

Medasil Surgical Limited is registered in the European database on medical devices as a manufacturer, with 138 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa136
Class IIb2

Among these devices, 124 are declared sterile.

Authorised representative in the Union: European Healthcare & Device Solutions Ltd..

Catalogue references include 261-1105-4820-0006, 261-1105-6425-0018, 261-1105-8024-0024, 261-1110-3216-0003, 410-110-8024, 410-1110-9516.

European nomenclature codes declared: A0399, V9099, A06010199, P020203, T0306, Q0399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED138
Country of registrationUnited Kingdom

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN138
Found in the U.S. device database1
Share0.7 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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: Neither register. Medasil Surgical Limited was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
GB24/00000131supplemented2029-06-13

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