Guangzhou Shengwei Medical Devices Co., Ltd.
Registered establishment in Guangzhou, Guangdong, China. 8 device types, 1 clearance.
Guangzhou Shengwei Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Marker, Skin, Bag, Reservoir and 6 other device types. Its earliest product listing with the FDA dates from 2019.
8device types registered with the FDA
1510(k) clearance
Registration
| Registered name | GUANGZHOU SHENGWEI MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015665020 |
| FEI number | 3015665020 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 广州晟威医疗器械有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | No.126, Guangshao Road, Aotou Town, Conghua District |
| Postal code | 510945 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable Nitrile Gloves, Powder Free, Powder Free, Disposable Nitrile Examination Gloves, Face Mask, Powder Free, Disposable Latex Gloves | 2020 | 439 |
| Airway, Nasopharyngeal | Class 1 | Anesthesia Airway Tubes or Disposable Nasopharyngeal Airway or Nasal Airway | 2023 | 52 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Swab | 2020 | 186 |
| Bag, Reservoir | Class 1 | Breathing Bags | 2019 | 28 |
| Container, Specimen, Non-Sterile | Class 1 | Viral Transport Medium Tube with Swab | 2020 | 115 |
| Marker, Skin | Class 1 | Skin Marker or Marking Pen or Skin Marker Pen or Disposable Skin Marker Pen | 2023 | 55 |
| Mask, Gas, Anesthetic | Class 1 | Anesthesia mask | 2019 | 71 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | goggle, eyewear, eye goggle, safety goggle | 2020 | 384 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K214063 | 2022-06-03 | KNW | Traditional | This company |
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.
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