EU → North America Device Access

Malvern Medical Developments Ltd also trading as PB Medical Ltd

GB-MF-000014481 · United Kingdom · Worcester

Malvern Medical Developments Ltd also trading as PB Medical Ltd is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa88

Most frequent device types declared: 100045001, 100080003, 100080017, 200045017, AH3956.

Among these devices, 46 are declared sterile.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 88 declared devices.

Catalogue references include 100080003, 100080005, 200045017, 500039015, 500039025, 500039034.

European nomenclature codes declared: G02060305, U050402, U05010101, U0580, U050199, G010302.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED88
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 GTIN88
Found in the U.S. device database3
Share3.4 %
⚠ 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. Malvern Medical Developments Ltd also trading as PB Medical Ltd was not found in either the U.S. or the Canadian register.

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