Data / Medical devices / China / Shanghai Jianzhong Medical Packaging Co., Ltd.
Shanghai Jianzhong Medical Packaging Co., Ltd.: FDA-registered device maker in Shanghai, China, 3 510(k) clearances
Shanghai Jianzhong Medical Packaging Co., Ltd. is registered with the FDA (registration 3005030944) in Shanghai, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005030944
- Address
- BLDG. No.16, 789#. Puxing Road Minhang District, Shanghai, China, 201114
- Owner or operator
- SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD. (9070517)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- June 5, 2016
- Registered through
- 2026
- Brand names listed
- Disposable surgical mask, Indicator, physical/chemical sterilization process, Sterilization Pouches and Reels, Wrap, sterilization
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 21, 2025 | K242898 | Sterilization Pouches and Reels | FRG | Substantially Equivalent | Shanghai Jianzhong Medical Packaging Co., Ltd. | accessdata.fda.gov |
| February 12, 2021 | K202341 | Disposable Surgical Mask | FXX | Substantially Equivalent | Shanghai Jianzhong Medical Packaging Co., Ltd. | accessdata.fda.gov |
| December 27, 2007 | K071886 | SELF SEAL STERILIZATION POUCH | FRG | Substantially Equivalent | Shanghai Jianzhong Medical Packaging Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Mask, Surgical
Updated February 21, 2025. 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.