Amico Diagnostic Station

FDA UDI

Class II (US FDA UDI)

by Amico Diagnostic Incorporated

Identity

Trade Name: Amico Diagnostic Station FDA UDI
Generic Name: Aneroid manual sphygmomanometer FDA UDI
Device Name: Diag Station Oph & Oto LED, Disp, L-Brackt Aneroid Adlt Cuff, Therm, Horiz Mount Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) 3000 AD Electronic Thermometer (DI 20884521008509) FDA UDI
Model / Reference: DS-UA1-CLFL-DLO FDA UDI
Description: Diag Station Oph & Oto LED, Disp, L-Brackt Aneroid Adlt Cuff, Therm, Horiz Mount Adult 2-Piece Cuff, 2 Tubes LF, Navy Blue, Infl Bulb x Screw Female Connector (DI 00697077000769) Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) 3000 AD Electronic Thermometer (DI 20884521008509) FDA UDI

Identifiers

Primary DI / UDI-DI: 00697077001162 FDA UDI
FDA Product Code: HLI FDA UDI
ERA FDA UDI
DXQ FDA UDI
FLL FDA UDI
GMDN Term: Aneroid manual sphygmomanometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1570 FDA UDI
874.4770 FDA UDI
870.1120 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Aneroid manual sphygmomanometer Intermittent electronic patient thermometer Direct ophthalmoscope

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

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JEDMED — JEDMED Instrument Company · Class II
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HEINE BETA® 200 Desk Set — Heine Optotechnik GmbH & Co. KG · Class II

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 dee5238d-3d4a-496c-83e8-b9ea2e4e3d43 34 fields · synced Jun 6, 2026