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Digital Medical Scope

FDA UDI

Class I (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name
DIGITAL MEDICAL SCOPE FDA UDI
Generic Name
Dermatoscope, digital FDA UDI
Device Name
DS-10G is a digital hand-held camera used to record digital photographs and video of the human body. FDA UDI
Model / Reference
DS-10G FDA UDI
Description
DS-10G is a digital hand-held camera used to record digital photographs and video of the human body. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669101049 FDA UDI
FDA Product Code
FXF FDA UDI
GMDN Term
Dermatoscope, digital FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.1800 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dermatoscope, digital

Digital Medical Scope by Nidek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatoscope, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nidek, Inc.

Sources (1)

  • FDA UDI f77fc493-a19c-4002-9005-130ed1388427 34 fields · synced May 30, 2026