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Waters Corporation

United States US-MF-000025801 Last updated 23 Oct 2026

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Devices
32
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
0

Catalogue32

Authorised representatives

What Waters Corporation makes

Waters Corporation manufactures analytical instruments for liquid chromatography, mass spectrometry, and immunoassay testing. Key products include HPLC systems (e.g., 515 HPLC Pump, Alliance 2690 Separations Module), fluorescence and absorbance detectors (e.g., 474 Scanning Fluorescence Detector, 2487 Dual Wavelength Absorbance Detector), sample management solutions (e.g., 2700 Sample Manager), and mass spectrometry software (e.g., MassLynx). The company also produces immunoassay kits for immunosuppressant drug monitoring (e.g., MASSTRAK Immunosuppressants Kit, MassTrak).

These devices are classified under EU and FDA regulations as Class A, B, Class I, and Class II. The company’s products are listed in the EU’s eudamed registry and the FDA’s 510(k) database. Waters Corporation is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
34, Maple Street, Milford, United States
Website
waters.com
PRRC contact
Raajdeep Venkatesan
EUDAMED SRN
US-MF-000025801
FDA FEI number
1218959