Data / Medical devices / China / Shantou Wealy Medical Instrument Co., Ltd.
Shantou Wealy Medical Instrument Co., Ltd.: FDA-registered device maker in SHANTOU Guangdong, China, 8 510(k) clearances
Shantou Wealy Medical Instrument Co., Ltd. is registered with the FDA (registration 3005202235) in SHANTOU Guangdong, China. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005202235
- Address
- North Jinhuan Road, SHANTOU Guangdong, China, 515064
- Owner or operator
- Shantou Wealy Medical Instrument Co., Ltd (9074040)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 10, 2005
- Registered through
- 2026
- Brand names listed
- Automatically Retractable Safety Syringes with Fixed Needle (1ml, 3ml, 10ml), Disposable Automatically Retractable Insulin Safety Syringe, Disposable Automatically Retractable Safety Syringes (with detachable needle), ENFit Disposable Enteral Syringe, ENFit Reusable Enteral Syringe, Reusable oral syringes, Sharps Safety Station Needle Counter Box, Wealy Antistick Syringe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cabinet, Table And Tray, Anesthesia | BRY | 1 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Contract manufacturer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| November 23, 2022 | K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | MEG | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| March 4, 2022 | K210216 | Disposable Automatically Retractable Insulin Safety Syringe | MEG | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| August 27, 2021 | K203613 | ENFit Reusable Enteral Syringe | PNR | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| June 28, 2021 | K203410 | ENFit Disposable Enteral Syringe | PNR | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| November 19, 2014 | K141640 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE | MEG | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| February 24, 2012 | K113587 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) | MEG | Substantially Equivalent | Shantou Wealy Medical Instrument Co.,Ltd | accessdata.fda.gov |
| June 12, 2006 | K060668 | SAFE TIP SYRINGE | MEG | Substantially Equivalent | Devon Safety Products, Inc. | accessdata.fda.gov |
| September 30, 2005 | K052551 | DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE | FMF | Substantially Equivalent | Devon Safety Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Syringe, Ent
- All makers of Cabinet, Table And Tray, Anesthesia
- All makers of Container, Liquid Medication, Graduated
- All makers of Syringe, Piston
Updated November 23, 2022. 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.