EU → North America Device Access

East Midlands Pharma Limited

GB-MF-000009146 · United Kingdom · Leicestershire

East Midlands Pharma 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

Most frequent device types declared: MDF002-Cleansing drops Formulation B-IRRIT, MDF003 - Moisturising Drops - Formulation A (0.1%), MDF003 - Moisturising Drops Formulation B (0.3%HPMC), MDF003 -Moisturising Drops - Formulation F (Vit A&E), MDF003- Moisturising Formulation A(0.3%HA).

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 8418/0002-P, IRRIT, MDF-002 Formulation A (0.3%), MDF002 - Formulation A (0.1%HA), MDF003-Moisturising Drops Formulation F (Vit A&E), MDF004 - Eye wash and Irrigation solution.

European nomenclature codes declared: Q02030206, Q02030299, Q03040299, Q030103, Q0299.

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 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: Neither register. East Midlands Pharma Limited was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ECM23MDR001supplemented2028-05-11

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