Data / Medical devices / Vietnam / Phu Bao Medical Co., Ltd
Phu Bao Medical Co., Ltd: FDA-registered device maker in Long An Province, Vietnam, 1 510(k) clearance
Phu Bao Medical Co., Ltd is registered with the FDA (registration 3016615220) in Long An Province, Vietnam. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016615220
- Address
- Lot C21, D2 Road, Cau Tram Industrial Park, Long Trach Ward Can Duoc Dist., Long An Province, Vietnam, 850000
- Owner or operator
- PHU BAO GROUP COMPANY LIMITED (10074628)
- Roles
- Manufacturer
- First device listed
- July 31, 2020
- Registered through
- 2026
- Brand names listed
- DRY PAD, FAMILEX Disposable High Filtration Face Mask, PINNAKLE MODERATE UNDERPAD, Perfetta Moderate Medical Face Mark, Perfetta Moderate Medical Face Mask, non sterile, non surgical gown
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | 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 |
|---|---|---|---|---|---|---|
| September 2, 2022 | K222426 | Perfetta Moderate Medical Face Mask | FXX | Substantially Equivalent | Phu Bao Group Company Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Bedding, Disposable, Medical
- All makers of Accessory, Surgical Apparel
- All makers of Non-Surgical Gown
Updated September 2, 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.