Data / Medical devices / China / Shanghai AnQing Medical Instrument Co., Ltd
Shanghai AnQing Medical Instrument Co., Ltd: FDA-registered device maker in Shanghai, China, 12 510(k) clearances
Shanghai AnQing Medical Instrument Co., Ltd is registered with the FDA (registration 3015139943) in Shanghai, China. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015139943
- Address
- 3&4 Floor,No.2 Building 366 Huiqing Rd, East Zhangjiang High-Tech Park, Shanghai, China, 201201
- Owner or operator
- Shanghai AnQing Medical Instrument CO., Ltd. (10058112)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 13, 2018
- Registered through
- 2027
- Brand names listed
- 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), Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US), Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US), Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US), Flexible Ureterorenoscope (US27F-12-EU, US27F-12-US), Flexible Ureterorenoscope (US31D-12-EU, US31D-12-US), Flexible Ureterorenoscope (US31E-12-EU, US31E-12-US) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | 2 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 26, 2026 | K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | HIH | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 3, 2025 | K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | FGB | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| September 15, 2025 | K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | FAJ | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| May 29, 2025 | K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | EOQ | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| April 11, 2025 | K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | FGB | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 17, 2023 | K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | FBN | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 9, 2022 | K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | FAJ | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 5, 2022 | K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | FGB | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 26, 2022 | K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) | FGB | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 24, 2021 | K211169 | Bronchoscope System | EOQ | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| July 24, 2020 | K201293 | Ureterorenoscope System | FGB | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
| July 3, 2018 | K180367 | Ureterorenoscope System | FGB | Substantially Equivalent | Shanghai AnQing Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Choledochoscope And Accessories, Flexible/Rigid
- All makers of Hysteroscope (And Accessories)
Updated February 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.