Spectrophotometers

Spectrophotometers

Form: UV-Vis spectrophotometers, Spectrophotometers (dual or multi-wavelength), Portable spectrophotometers

Strength: High accuracy, broad wavelength ranges (190-1100 nm), advanced software, validated for clinical and research applications, FDA-registered models

Reference Brands: Thermo Scientific, Shimadzu, Beckman Coulter, Agilent, BioTek

Category: Medical Devices

Spectrophotometers marketed in the EU and US are regulated to ensure safety, accuracy, and reliable performance. In the US, FDA approval requires validation, safety testing, and GMP compliance, especially for clinical and diagnostic models. In the EU, CE marking certifies conformity with the Medical Device Regulation (MDR). Devices undergo validation, stability testing, and audits, supported by dossiers including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to high-quality, accurate spectrophotometers vital for diagnostics, research, and industrial analysis worldwide, supporting scientific and healthcare advancements.

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