Shantou Wealy Medical Instrument Co., Ltd.
Manufacturer and brand owner in Shantou, Guangdong, China. 10 device types, 2 products catalogued, 6 clearances.
Shantou Wealy Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Ent, Syringe, Piston and 8 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005202235 |
| FEI number | 3005202235 |
| DUNS | 545570186 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 汕头华尔怡医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440500733128802G |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shantou |
|---|---|
| Province | Guangdong |
| Address | NORTH JINHUAN ROAD |
| Postal code | 515064 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cabinet, Table And Tray, Anesthesia | Class 1 | epidural tray | 2007 | 22 |
| Container, Liquid Medication, Graduated | Class 1 | Reusable oral syringes | 2023 | 68 |
| Enteral Syringes With Enteral Specific Connectors | Class 2 | ENFit Reusable Enteral Syringe, ENFit Disposable Enteral Syringe | 2021 | 13 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Wealy Gauze | 2007 | 266 |
| Instrument, Manual, Surgical, General Use | Class 1 | Sharps Safety Station Needle Counter Box | 2011 | 110 |
| Needle, Hypodermic, Single Lumen | Class 2 | Disposable Automatically Retractable Safety Syringes (with detachable needle), Wealy Syringe | 2005 | 71 |
| Syringe, Antistick | Class 2 | Wealy Antistick Syringe, Disposable Automatically Retractable Safety Syringes (with detachable needle), Disposable Automatically Retractable Insulin Safety Syringe, Wealy Syringe, Automatically Retractable Safety Syringes with Fixed Needle (1ml, 3ml, 10ml) | 2005 | 39 |
| Syringe, Ent | Class 1 | Wealy Syringe | 2005 | 24 |
| Syringe, Irrigating (Non Dental) | Class 1 | Wealy Syringe | 2005 | 110 |
| Syringe, Piston | Class 2 | Disposable Automatically Retractable Safety Syringes (with detachable needle), Disposable Automatically Retractable Insulin Safety Syringe, Wealy Syringe | 2005 | 60 |
Own-Brand Listings
Clearances
6 clearances name Shantou Wealy Medical Instrument Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222452 | 2022-11-23 | MEG | Traditional | This company |
| K210216 | 2022-03-04 | MEG | Traditional | This company |
| K203613 | 2021-08-27 | PNR | Traditional | This company |
| K203410 | 2021-06-28 | PNR | Traditional | This company |
| K141640 | 2014-11-19 | MEG | Traditional | This company |
| K113587 | 2012-02-24 | MEG | Traditional | This company |
| K060668 | 2006-06-12 | MEG | Traditional | Devon Safety Products, Inc. |
| K052551 | 2005-09-30 | FMF | Traditional | Devon Safety Products, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 23500 |
|---|---|
| Main products | safety syringes, hypodermic needles, infusion sets |
| Certifications | FDA 510K, Patents in 20+ countries |
| Export markets | US, Brazil, EU countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.