EU → North America Device Access

Juvora Limited

GB-MF-000007895 · United Kingdom · Thornton-Cleveleys

Juvora Limited is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Among these devices, 13 are declared implantable.

Authorised representative in the Union: Psephos Limited.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 760403, 760410, DD-98-18-02 Natural, DD-98-20-02 Natural, DD-98-20-02 Oyster White, DD-98-22-02 Oyster White.

European nomenclature codes declared: Q0102050199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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 GTIN13
Found in the U.S. device database13
Share100.0 %
⚠ 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. Juvora Limited was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
GB23/00000417issued2028-12-18

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