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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 system capsule FDA UDI
Device Name
The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract. FDA UDI
Model / Reference
Capsule/AKES-11SW FDA UDI
Description
The Capsule is a capsule endoscope capable of capturing images inside the human digestive tract. FDA UDI

Identifiers

Catalog Number
CP-US-7005, CP-US-7006 FDA UDI
Primary DI / UDI-DI
06921010800494 FDA UDI
FDA Product Code
NEZ FDA UDI
GMDN Term
Video capsule endoscopy system capsule 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Video capsule endoscopy system capsule

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 system capsule.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ANKON Technologies Co., Ltd.

Sources (1)

  • FDA UDI f086d5f3-b0c7-4d37-838b-c5448c1982c1 35 fields · synced Jun 8, 2026