Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020369549

FEI Number

3020369549

Entity Name

NINGBO WISE OPTOMECH TECHNOLOGY CORPORATION

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

2F, Building 12, Sankari Park, 688 Jinda Road, Yinzhou District, Ningbo Zhejiang 315100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ningbo Wise Optomech Technology Corporation (Owner Number: 10058762)

Owner / Operator Contact Address

No.86, Building 11, Innovation Park 128, Qiming Road, Yinzhou District,, Ningbo,, CN-ZJ 315000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WiScope® Single-Use Digital Flexible Bronchoscope WiScope® Image System WiScope Digital Bronchoscope System WiScope® Image System WiScope® OM Endoscope System WiScope® Single-Use Digital Flexible Ureteroscope/Choledochoscope WiScope® Image System WiScope® Digital Endoscope System WiScope® Single-Use Digital Flexible UroScope WiScope® Single-Use Digital Flexible Ureteroscope Aptra Single-Use Digital Flexible Ureteroscope Aptra Image System Aptra Digital Endoscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-11-18
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-05
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-08-05
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-10-25

Official Correspondent

Jingjing Wei

US Agent Details

Geping Liu Business: OTU Medical Inc. Email: Geping.liu@otumed.com Phone: (408) 7977313

Related Public Records

Same Entity

Ningbo Wise Optomech Technology Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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3015970743	CENTERPOINT SYSTEMS LLC	West Valley City, UT, US
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020369549. Last updated year: 2026. Please use registration number 3020369549 when referencing this establishment in official correspondence.