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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
Endoscope camera adaptor FDA UDI
Device Name
The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of the body. FDA UDI
Model / Reference
DS-10 Control Unit FDA UDI
Description
The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of the body. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669101070 FDA UDI
FDA Product Code
FTT FDA UDI
ERA FDA UDI
FSP FDA UDI
FXF FDA UDI
HKI FDA UDI
GMDN Term
Endoscope camera adaptor FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4160 FDA UDI
874.4770 FDA UDI
878.4800 FDA UDI
878.1800 FDA UDI
886.1120 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Otoscope, directOphthalmic fundus cameraEndoscope camera adaptorDermatoscope, 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 ff5f5ac8-5a21-4ef8-b382-bb5d18383244 34 fields · synced May 30, 2026