Haag-Streit UK Ltd

Haag-Streit UK Ltd specialises in ophthalmic diagnostic accessories. These include items like the Tonosafe Prism Holder Pack, which aids in slit-lamp examinations, and spare weights for tonometry devices. These products are designed to enhance precision in eye care diagnostics by ensuring compatibility with existing equipment.

The company is based in the United Kingdom (UK), operating under the jurisdiction of GB. This location influences its regulatory compliance, particularly for devices marketed within the European Union.

Haag-Streit UK Ltd’s devices are registered in the eudamed database, which is the official EU portal for medical device information. This registry ensures transparency and compliance with the EU Medical Device Regulation (MDR) for devices marketed in the European Economic Area.

The company’s devices fall under Class I classification according to the EU Medical Device Regulation (MDR). This classification applies to low-risk accessories like the Tonosafe Prism Holder Pack and spare weights, which do not require invasive procedures or pose significant health risks. Class I devices still must meet essential safety and performance requirements but have streamlined regulatory pathways.