Data / Medical devices / China / Weihai Xingtai Packaging Products Co., Ltd.
Weihai Xingtai Packaging Products Co., Ltd.: FDA-registered device maker in WeiHai Shandong, China, 3 510(k) clearances
Weihai Xingtai Packaging Products Co., Ltd. is registered with the FDA (registration 3017220525) in WeiHai Shandong, China. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 17, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017220525
- Address
- No. 99, Pingzhi Road, Yangting Town, Huancui Area, WeiHai Shandong, China, 264204
- Owner or operator
- Weihai Xingtai Packaging Products Co., Ltd. (10074054)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 18, 2020
- Registered through
- 2027
- Brand names listed
- Autoclave Indicator Tape; EO Indicator Tape, Barrier Film, Cotton applicator, Cotton gauze, Denal Apron;Dental bibs, Dental cotton roll, Diposable Medical Device Self-seal Sterilization Pouch, Diposable Medical Device Self-seal Sterilization Pouch-135mm*190mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | 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 |
|---|---|---|---|---|---|---|
| December 17, 2024 | K241036 | Autoclave Indicator Tape; EO Indicator Tape | JOJ | Substantially Equivalent | Jiangmen New Era External Use Drug Co., Ltd. | accessdata.fda.gov |
| April 15, 2020 | K193561 | Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | FRG | Substantially Equivalent | Weihai Xingtai Packaging Products Co., Ltd. | accessdata.fda.gov |
| August 19, 2019 | K183356 | Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch | FRG | Substantially Equivalent | Weihai Xingtai Packaging Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Occlusive
- All makers of Absorber, Saliva, Paper
- All makers of Shield, Protective, Personnel
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Holder, Film, X-Ray
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated December 17, 2024. 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.