Davis Schottlander & Davis Ltd

Davis Schottlander & Davis Ltd specialises in radiation shielding aprons, silicone-based dental impression materials (including opaque pastes like Propaque Paste), and nitrile examination gloves for medical and dental use. They also produce digital dental imaging systems under the enigmalife brand. These products cater to radiation protection, dental diagnostics, and clinical examination needs.

The company is based in Great Britain, which means its devices fall under the EU Medical Device Regulations (MDR) framework. Since the UK is part of the EU regulatory system, their products are listed in the EUDAMED database, a centralised EU registry for medical devices. This ensures traceability and compliance with EU requirements for devices classified as Class I or Class IIa.

The company’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry tracks devices authorised under the EU Medical Device Regulations (MDR), including those classified as Class I or Class IIa. EUDAMED ensures transparency and compliance for healthcare professionals and regulators.

The company’s devices are classified under the EU Medical Device Regulations (MDR) as either Class I (low-risk devices like some gloves or dental impression materials) or Class IIa (moderate-risk devices, such as radiation shielding aprons or certain digital imaging systems). Classification depends on factors like intended use, risk potential, and interaction with the body, determining the regulatory scrutiny required.

The most commonly used devices in clinical settings are likely the radiation shielding aprons (for protecting healthcare workers from X-rays) and silicone dental impression materials (like Propaque Paste), which are essential for creating accurate dental moulds. Their nitrile examination gloves are also widely used in medical and dental procedures due to their durability and barrier properties. Digital imaging systems under the enigmalife brand may also be utilised in dental practices.