Amico Diagnostic Rollstand

FDA UDI

Class II (US FDA UDI)

by Amico Diagnostic Incorporated

Identity

Trade Name: Amico Diagnostic Rollstand FDA UDI
Generic Name: Intermittent electronic patient thermometer FDA UDI
Device Name: Diag. Station - Ophthal & Oto LED, Spec Dispenser, Pred. Therm, on Mobile Stand Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) 3000 AD Electronic Thermometer (DI 20884521008509) FDA UDI
Model / Reference: DS-UR1-CLFL-DXO FDA UDI
Description: Diag. Station - Ophthal & Oto LED, Spec Dispenser, Pred. Therm, on Mobile Stand Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) 3000 AD Electronic Thermometer (DI 20884521008509) FDA UDI

Identifiers

Primary DI / UDI-DI: 00697077002299 FDA UDI
FDA Product Code: HLI FDA UDI
ERA FDA UDI
FLL FDA UDI
GMDN Term: Intermittent electronic patient thermometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1570 FDA UDI
874.4770 FDA UDI
880.2910 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

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent electronic patient thermometer Direct ophthalmoscope

Amico Diagnostic Rollstand 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 487bfdf6-1757-4d61-af49-bbde51fffb19 33 fields · synced May 30, 2026