Diagnostix™

FDA UDI

Class I (US FDA UDI)

by American Diagnostic Corporation

Identity

Trade Name: Diagnostix™ FDA UDI
Generic Name: Dermatoscope, optical FDA UDI
Device Name: Adstation Oto+-L ,Derm, Clock Aner, EU FDA UDI
Model / Reference: 5681L-57EU FDA UDI
Description: Adstation Oto+-L ,Derm, Clock Aner, EU FDA UDI

Identifiers

Catalog Number: 5681L-57EU FDA UDI
Primary DI / UDI-DI: 00634782092924 FDA UDI
FDA Product Code: IBJ FDA UDI
HLJ FDA UDI
ERA FDA UDI
DXQ FDA UDI
GMDN Term: Dermatoscope, optical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3600 FDA UDI
886.1570 FDA UDI
874.4770 FDA UDI
870.1120 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Aneroid manual sphygmomanometer Ophthalmic/otologic diagnostic set Dermatoscope, optical

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

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Also classified as Dermatoscope, optical.

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Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
DL4 Magnetic Eyepiece — DermLite LLC · Class I
DermLite Carbon — DermLite LLC · Class I
CONTACT PLATE MINI3000 — Heine Optotechnik GmbH & Co. KG · Class I
DermLite DL5 — DermLite LLC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: American Diagnostic Corporation

Sources (1)

FDA UDI 534aa428-8c73-4546-b6fe-ac0232850911 36 fields · synced May 31, 2026