EU → North America Device Access

PolarSeal Tapes and Conversions Ltd

GB-MF-000029062 · United Kingdom · Farnham

PolarSeal Tapes and Conversions Ltd is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb16

Most frequent device types declared: 311-050 Manuka IG 5.1x5.1cm, 311-125 Manuka IG 10.2x12.7cm, 321-050 Manuka IG Max pouch 5.1x5.1cm, 321-100 Manuka IG Max 10.2x10.2cm, 322-305 Manuka IG Max Rope 2.5x30.5cm.

Among these devices, 16 are declared sterile.

Authorised representative in the Union: MedEnvoy Global BV.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 311-125, 321-050, 322-305, 332-100, WC05 ECT 42.5g tube Primary carton (1), WC20-ECT.

European nomenclature codes declared: M040204.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPOLARSEAL TAPES AND CONVERSIONS LTD (GB) · FDA 3013526501
Devices in EUDAMED16
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN16
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: United States only. PolarSeal Tapes and Conversions Ltd is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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