EU → North America Device Access

Bailey Instruments Ltd.

GB-MF-000013119 · United Kingdom · Manchester

Bailey Instruments Ltd. is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa38

Most frequent device types declared: Monofilament, Retractable Monofilament, SS04-0100, SS07-0311L, SS30-2601.

Among these devices, 36 are declared sterile.

Authorised representative in the Union: MD REPS Ltd.

Devices declared under this manufacturer

Showing 12 of 38 declared devices.

Catalogue references include BSDP-01A, CH534, S-DB4, S-TQM, SS04-0106-F, SS08-0539.

European nomenclature codes declared: V901699, V0199, H010201010102, V901603.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBailey Instruments Ltd (GB) · FDA 3001084743
Devices in EUDAMED38
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN38
Found in the U.S. device database31
Share81.6 %

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. Bailey Instruments Ltd. is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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