EU → North America Device Access

Haag-Streit UK Ltd

GB-MF-000013117 · United Kingdom · Bishop's Stortford

Haag-Streit UK Ltd is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11

Most frequent device types declared: BOX OF 20 TONOSAFE & 1 HOLDER, Perkins MK3 Aus, Perkins MK3 China, Perkins MK3 Jap/Can, Perkins MK3 UK (Tonosafe).

Among these devices, 3 are declared sterile, 6 active.

Authorised representative in the Union: Haag-Streit Deutschland GmbH.

Devices declared under this manufacturer

Catalogue references include 4701001, 5801004-5, 5805084PACK, 5805091, 5805100, 5806001A.

European nomenclature codes declared: Z12120122, Q0299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHAAG-STREIT UK LTD. (GB) · FDA 3004950803
Devices in EUDAMED11
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN11
Found in the U.S. device database2
Share18.2 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryHAAG STREIT UK LTD

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2004-07-06

Licence types: Single Device (2), Device Family (1).

Licensed under: TONOSAFE DISPOSABLE PRISM, SCHIRMER TEAR TEST STRIPS, PERKINS MK3 TONOMETER.

North American profile: Both markets. Haag-Streit UK Ltd is registered in both the United States and Canada.

Other manufacturers in United Kingdom

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