Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1220253

FEI Number

1220253

Entity Name

SDI DIAGNOSTICS, INC.

City/State/Country

South Easton, MA, US

Establishment Address

10 Hampden Dr, South Easton, MA 02375, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SDI DIAGNOSTICS, INC (Owner Number: 1220253)

Owner / Operator Contact Address

10 HAMPDEN DR., --, South Easton, MA 02375, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Astraguard, Filtrette, Filtrette A Bacterial Viral Filters Pulmoguard Safe-t-Check, Oval, Accurette, Air Tube Mouthpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2012-04-13
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-04-13
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2014-02-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SDI DIAGNOSTICS, INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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3006895489	MEDIKRO OY	Kuopio Pohjois-Savo, FI
3014128536	MEDCHIP SOLUTIONS LIMITED	Chatham Kent, GB
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220253. Last updated year: 2026. Please use registration number 1220253 when referencing this establishment in official correspondence.