Aed Endopro-Cam®

FDA UDI

Class I (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name: AED ENDOPRO-CAM® FDA UDI
Generic Name: Endoscope video camera FDA UDI
Device Name: AED ENDOPRO-CAM® ELITE Portable HD Endoscopic Video System: An electro-optical device (e.g., with an image sensor chip) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. This device includes a camera stand and rechargeable battery. FDA UDI
Model / Reference: EP2000 FDA UDI
Description: AED ENDOPRO-CAM® ELITE Portable HD Endoscopic Video System: An electro-optical device (e.g., with an image sensor chip) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. This device includes a camera stand and rechargeable battery. FDA UDI

Identifiers

Catalog Number: EP2000 FDA UDI
Primary DI / UDI-DI: 00848657068192 FDA UDI
FDA Product Code: FWD FDA UDI
FWF FDA UDI
KQM FDA UDI
GMDN Term: Endoscope video camera FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4160 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope video camera

Aed Endopro-Cam® by National Advanced Endoscopy Devices, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: National Advanced Endoscopy Devices, Inc.

Sources (1)

FDA UDI 40a8a1d4-a9a8-43f7-b7be-815965c17b0a 35 fields · synced Jun 8, 2026