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SDI DIAGNOSTICS, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
10 Hampden Dr, South Easton, MA, 02375
Website
—
LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
1220253
DUNS Number
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Catalogue (423)

Page 9 of 9
DeviceModel / ReferenceRegistriesClassStatus
Astra Spirometer 100
FDA UDI
Class IIUnknown
Astra Spirometer 200
FDA UDI
Class IIUnknown
Astra Spirometer 300
FDA UDI
Class IIUnknown
Astra Spirometer Touch
FDA UDI
Class IIUnknown
Astra Spirometer 200
FDA UDI
Class IIUnknown
Astra Spirometer 200
FDA UDI
Class IIUnknown
Astra Spirometer Touch
FDA UDI
Class IIUnknown
Astra Spirometer 100
FDA UDI
Class IIUnknown
Astra Spirometer Touch
FDA UDI
Class IIUnknown
Astra Spirometer 300
FDA UDI
Class IIUnknown
Filtrette Filtrette
FDA UDI
Class IIActive
Astra Spirometer 300
FDA UDI
Class IIUnknown
Astra Spirometer Touch
FDA UDI
Class IIUnknown
Astrasonic Spirometer, Model 29-8000 K092813
FDA 510(k)
Class IIActive
Sdi Sb Office, Model 29- K011470
FDA 510(k)
Class IIActive
Flosense, Model 29-8010 K990962
FDA 510(k)
Class IIActive
Spirotel, Model 29-1020 K031643
FDA 510(k)
Class IIActive
Spirolab Ii, Model 29 K013812
FDA 510(k)
Class IIActive
Astraguard Pulmonary Function Filter K062913
FDA 510(k)
Class IIActive
Astra 300 K061571
FDA 510(k)
Class IIActive
IQSense Flow Sensor Mouthpiece K150515
FDA 510(k)
Class IIActive
Flosense Ii, Model 29-8040 K033939
FDA 510(k)
Class IIActive
Pulmoguard Disposable Baterial/Viral Filter K934509
FDA 510(k)
Class IIActive

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