Data / Medical devices / China / Shanghai Draeger Medical Instrument Co., Ltd.
Shanghai Draeger Medical Instrument Co., Ltd.: FDA-registered device maker in Shanghai, China, 3 510(k) clearances
Shanghai Draeger Medical Instrument Co., Ltd. is registered with the FDA (registration 3019545235) in Shanghai, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 24, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3019545235
- Address
- 3#, No.229, Hupo Road Shanghai International Medical Zone, Shanghai, China, 201321
- Owner or operator
- Shanghai Draeger Medical Instrument Co., Ltd. (10085938)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- November 30, 2025
- Registered through
- 2026
- Brand names listed
- Adapter M34x1.5 to 9/16, Adapter 9/16" to 6mm nozzle, IBP transducer adapter cable, Abbott/Medex, Smiths/TranStar 2m, IBP transducer adapter cable, Abbott/Medex,Smiths, IBP transducer adapter cable, Argon/BD/Ohmeda,0.3m, IBP transducer adapter cable, Argon/BD/Ohmeda,2m, IBP transducer adapter cable, Baxter/Edwards,0.3m, IBP transducer adapter cable, Baxter/Edwards,2m, IBP transducer adapter cable, Codan/DPT,2m and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Specification developer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 24, 2026 | K250349 | Vista CMS | MHX | Substantially Equivalent | Shanghai Draeger Medical Instrument Co., Ltd. | accessdata.fda.gov |
| April 10, 2026 | K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | MHX | Substantially Equivalent | Shanghai Draeger Medical Instrument Co., Ltd. | accessdata.fda.gov |
| September 30, 2025 | K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | DSA | Substantially Equivalent | Shanghai Draeger Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Connector, Airway (Extension)
- All makers of Medical Device Data System
Updated April 24, 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.