NaviCam Small Bowel Capsule Endoscopy System

FDA UDI

Class II (US FDA UDI)

by ANKON Technologies Co., Ltd.

Identity

Trade Name: NaviCam Small Bowel Capsule Endoscopy System FDA UDI
Generic Name: Video capsule endoscopy monitoring kit FDA UDI
Device Name: The AKR-1 Data Recorder is a portable data receiving unit with built-in rechargeable lithium battery placed inside the examination cloth worn by the patient during examination. It is used for receiving image data wirelessly transmitted from the Capsule. FDA UDI
Model / Reference: Recorder/AKR-1 FDA UDI
Description: The AKR-1 Data Recorder is a portable data receiving unit with built-in rechargeable lithium battery placed inside the examination cloth worn by the patient during examination. It is used for receiving image data wirelessly transmitted from the Capsule. FDA UDI

Identifiers

Catalog Number: MC-US-1006 FDA UDI
Primary DI / UDI-DI: 06921010800517 FDA UDI
FDA Product Code: NEZ FDA UDI
GMDN Term: Video capsule endoscopy monitoring kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1300 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

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

Yes

FDA UDI

Category: Video capsule endoscopy monitoring kit

NaviCam Small Bowel Capsule Endoscopy System by ANKON Technologies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy monitoring kit.

NaviCam Stomach System — ANX ROBOTICA CORP. · Class II
NaviCam Capsule Endoscope System — ANX ROBOTICA CORP. · Class II
NaviCam Small Bowel Capsule Endoscopy System — ANKON Technologies Co., Ltd. · Class II
NaviCam Small Bowel Capsule Endoscopy System — ANKON Technologies Co., Ltd. · 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: ANKON Technologies Co., Ltd.

Sources (1)

FDA UDI 192865f0-a4a0-48d6-9e30-d6000dacad95 35 fields · synced Jun 8, 2026