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
Catalogue
MassTrak™ Ref 186008441IVD
MassLynx Ref 667004007
Masstrak Immunosuppressants Kit Ref K063868
2700 Sample Manager Ref K980180
Alliance 2690 Separations Module Ref K961557
Waters 474 Scanning Flourescence Detector (474) Ref K962574
Waters 515 Hplc Pump (515) Ref K964588
2487 Dual Wavelength Absorbance Detector Ref K973074
MassTrak™ Steroid Serum Cal Set 2 Ref 186010563IVD
Waters 3777C Sample Manager IVD Ref 725000662IVD
ACQUITY UPLC I-Class PLUS SM-FL IVD Ref 186015087IVD
MassLynx Ref 667007237DD
MassTrak™ Steroid Serum Cal Set 3 Ref 186010565IVD
MassTrak™ Ref 186008097IVD
Acquity Ref 186015042IVD
Xevo Tqd Ivd Ref 186005833IVD
MassTrak™ Steroid Serum QC Set 1 Ref 186009312IVD
ACQUITY UPLC I-Class PLUS SM-FTN IVD Ref 186015088IVD
MassTrak™ Steroid Serum Cal Set 1 Ref 186009311IVD
Waters_Connect Ref 667007225DD
Acquity Ref 186015000IVD
Acquity Uplc Cm-A Ivd Ref 186015043IVD
ACQUITY UPLC I-Class PLUS BSM IVD Ref 186015082IVD
MassTrak™ Ref 186010560IVD
Xevo TQ-XS IVD Ref 186008453IVD
Xevo TQ Absolute IVD Ref 186009782IVD
Acquity Ref 186015014IVD
XEVO TQ-S micro IVD Ref 186007833IVD
Acquity Ref 186015046IVD
MassTrak™ Steroid Serum QC Set 2 Ref 186010564IVD
MassTrak™ Ref 186008096IVD
MassTrak™ Steroid Serum QC Set 3 Ref 186010566IVD
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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.
Information
- Country
- United States
- Address
- 34, Maple Street, Milford, United States
- Website
- waters.com
- [email protected]
- PRRC contact
- Raajdeep Venkatesan
- EUDAMED SRN
- US-MF-000025801
- FDA FEI number
- 1218959