Amico Diagnostic Station

FDA UDI

Class II (US FDA UDI)

by Amico Diagnostic Incorporated

Identity

Trade Name: Amico Diagnostic Station FDA UDI
Generic Name: Infrared patient thermometer, ear FDA UDI
Device Name: Diagnostic Stn -Oph Hal & Oto LED, Spec Disp, Anroid & Bskt Adult Cuff, IR Therm Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) Diagnostic Station Wall Mount, Ophthal Halogen & Oto LED (DI 00697077001308) Genius 3 Tympanic Thermometer and Base (DI 10884521738522) FDA UDI
Model / Reference: DS-UDM-CHFL-DAI FDA UDI
Description: Diagnostic Stn -Oph Hal & Oto LED, Spec Disp, Anroid & Bskt Adult Cuff, IR Therm Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) Diagnostic Station Wall Mount, Ophthal Halogen & Oto LED (DI 00697077001308) Genius 3 Tympanic Thermometer and Base (DI 10884521738522) FDA UDI

Identifiers

Primary DI / UDI-DI: 00697077002367 FDA UDI
FDA Product Code: FLL FDA UDI
DXQ FDA UDI
ERA FDA UDI
HLI FDA UDI
GMDN Term: Infrared patient thermometer, ear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
870.1120 FDA UDI
874.4770 FDA UDI
886.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Aneroid manual sphygmomanometer Direct ophthalmoscope Infrared patient thermometer, ear

Amico Diagnostic Station by Amico Diagnostic Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Amico Diagnostic Incorporated

Sources (1)

FDA UDI c07031b1-9fa0-4bcc-a9f3-8bf33c52c78d 34 fields · synced Jun 8, 2026