Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025349506

FEI Number

3025349506

Entity Name

JIANA STERILIZATION TECHNOLOGY (CHANGSHA) CO., LTD

City/State/Country

changsha Hunan, CN

Establishment Address

No. 101, Building 31, Jinyang Intelligent Center, Kangping Road, Liuyang Economic and, Technological Development Zone, changsha Hunan 410300, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Jiana Sterilization Technology (Changsha) Co., LTD (Owner Number: 10086174)

Owner / Operator Contact Address

No. 101, Building 31, Jinyang Intelligent Center, Kangping Road, Liuyang Economic and, Technological Development Zone, changsha, CN-HN 410300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vathin® Video Bronchoscope System Single-Use Flexible Cystoscope Single-use flexible Video Bronchoscope Single-Use Flexible Ureteroscope

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	2023-12-18
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-10-19
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-12-18

Official Correspondent

Jun Zhou

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Jiana Sterilization Technology (Changsha) Co., LTD

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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8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP
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 3025349506. Last updated year: 2026. Please use registration number 3025349506 when referencing this establishment in official correspondence.