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 Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position. FDA UDI
Model / Reference: Locator/AKS-1 FDA UDI
Description: The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position. FDA UDI

Identifiers

Catalog Number: SB-US-2006 FDA UDI
Primary DI / UDI-DI: 06921010800531 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 d1ae7db8-98c8-4608-82a4-d26054c8405b 35 fields · synced May 29, 2026