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Diagnostix™

FDA UDI

Class II (US FDA UDI)

by American Diagnostic Corporation

Identity

Trade Name
Diagnostix™ FDA UDI
Generic Name
Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
Device Name
Adstation Oto-Xen/Derm-LED, 429, ,9003W/Spec Disp, WB, EU FDA UDI
Model / Reference
5611X-3458EUW FDA UDI
Description
Adstation Oto-Xen/Derm-LED, 429, ,9003W/Spec Disp, WB, EU FDA UDI

Identifiers

Catalog Number
5611X-3458EUW FDA UDI
Primary DI / UDI-DI
00634782097592 FDA UDI
FDA Product Code
DXN FDA UDI
ERA FDA UDI
HLJ FDA UDI
FLL FDA UDI
IBJ FDA UDI
GMDN Term
Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
874.4770 FDA UDI
886.1570 FDA UDI
880.2910 FDA UDI
864.3600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic/otologic diagnostic setInfrared patient thermometer, skinAutomatic-inflation electronic sphygmomanometer, non-portableDermatoscope, optical

Diagnostix™ by American Diagnostic Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatoscope, optical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Diagnostic Corporation

Sources (1)

  • FDA UDI 29502a4d-9022-4208-8929-34f49eafd90b 36 fields · synced May 30, 2026