Eview

FDA UDI

Class II (US FDA UDI)

by Zhuhai Pusen Medical Technology Co, Ltd

Identity

Trade Name: Eview FDA UDI
Generic Name: Endoscopic video image processing unit FDA UDI
Device Name: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney FDA UDI
Model / Reference: UTV100 FDA UDI
Description: This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney FDA UDI

Identifiers

Primary DI / UDI-DI: 06971176280005 FDA UDI
510(k) Number: K172098 FDA UDI
FDA Product Code: FGB FDA UDI
GMDN Term: Endoscopic video image processing unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

Sterilization Method

High-level Disinfectant FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Endoscopic video image processing unit

Eview by Zhuhai Pusen Medical Technology Co, Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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3NT Video Console — 3nt Medical , Ltd. · Class II
HDMI cable — MacroLux Medical Technology Co., Ltd. · Class II

Cleared under the same submission

K172098 also covers:

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: Zhuhai Pusen Medical Technology Co, Ltd

Sources (1)

FDA UDI 80d6628d-5b0b-4fae-bbeb-18a1c3b6bd95 34 fields · synced Jun 6, 2026