Shanghai AnQing Medical Instrument Co., Ltd

FDA Device Registration & Listing · Shanghai, CN · Registration 3015139943

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015139943
FEI Number
3015139943
Entity Name
Shanghai AnQing Medical Instrument Co., Ltd
City/State/Country
Shanghai, CN
Establishment Address
3&4 Floor,No.2 Building, 366 Huiqing Rd , East Zhangjiang High-Tech Park, Shanghai 201201, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shanghai AnQing Medical Instrument CO., Ltd. (Owner Number: 10058112)
Owner / Operator Contact Address
3rd Floor, No.2 Building,, 366 Huiqing Rd , East Zhangjiang High-Tech Park, Shanghai, CN-SH 201201, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231105
PMA Number
N/A

All Registered Proprietary Names

Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US) Video Processor (EOS-B-01) Flexible Ureteroscope (US31A-12, US31B-12) Portable Video Processor (EA101) Flexible Bronchoscope (BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US) Flexible Bronchoscope (BS50H-20EU,BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US) InnovexView (GC146-17, GC150-20, GC155-23) Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-12-03
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2018-08-13
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2025-06-05
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-03-02
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2026-03-02
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-11-18
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-09-24
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Shanghai AnQing Medical Instrument CO., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3035484431 Innovex Medical (Malaysia) Sdn.Bhd Gelang Patah Johor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
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
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16

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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3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015139943. Last updated year: 2026. Please use registration number 3015139943 when referencing this establishment in official correspondence.
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