Shantou Wealy Medical Instrument Co., Ltd.
SHANTOU Guangdong, CN
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. appears in FDA device records in SHANTOU Guangdong, CN. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Shantou Wealy Medical Instrument Co., Ltd. between 2012 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | MEG | Substantially Equivalent | |
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | MEG | Substantially Equivalent | |
| K203613 | ENFit Reusable Enteral Syringe | PNR | Substantially Equivalent | |
| K203410 | ENFit Disposable Enteral Syringe | PNR | Substantially Equivalent | |
| K141640 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE | MEG | Substantially Equivalent | |
| K113587 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) | MEG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005202235 | 3005202235 | SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. | NORTH JINHUAN ROAD, SHANTOU Guangdong 515064 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BRYCabinet, Table And Tray, Anesthesia
- KYWContainer, Liquid Medication, Graduated
- PNREnteral Syringes With Enteral Specific Connectors
- NABGauze / Sponge,Nonresorbable For External Use
- MDMInstrument, Manual, Surgical, General Use
- FMINeedle, Hypodermic, Single Lumen
- MEGSyringe, Antistick
- KCPSyringe, Ent
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain