Xiamen Probtain Medical Technology Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 10 device types, 1 clearance.
Xiamen Probtain Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Gown, Surgical and 8 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016680688 |
| FEI number | 3016680688 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 厦门美润医疗科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | No. 1 & No.3 Building, No.6, Ji’an Road, Tong’an District |
| Postal code | 361100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bedding, Disposable, Medical | Class 1 | Bed Mattress | 2020 | 308 |
| Cap, Surgical | Class 1 | Caps | 2020 | 178 |
| Dress, Surgical | Class 1 | Surgical Gown | 2020 | 71 |
| Fiber, Medical, Absorbent | Class 1 | Bed Sheet | 2020 | 172 |
| Garment, Protective, For Incontinence | Class 1 | Adult Nursing Pad, Baby Care Mat, Adult Diapers, Baby Diapers, Adult Insert Diapers | 2020 | 181 |
| Gown, Isolation, Surgical | Class 2 | Disposable Isolation Gowns (S, M, L, XL, XXL, XXXL) | 2023 | 21 |
| Gown, Surgical | Class 2 | Disposable Surgical Gowns (S, M, L, XL, XXL, XXXL) | 2023 | 68 |
| Mask, Scavenging | Class 1 | Face Mask | 2020 | 158 |
| Mask, Surgical | Class 2 | Disposable Surgical Mask | 2020 | 125 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
Clearances
1 clearance names Xiamen Probtain Medical Technology Co., Ltd. as applicant. 4 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 |
|---|---|---|---|---|
| K223304 | 2023-02-08 | FYC | Traditional | This company |
| K223401 | 2023-03-07 | FYA | Traditional | Xiamen Probtain Medical Techology Co., Ltd. |
| K223411 | 2023-01-04 | FYC | Traditional | Xiamen Probtain Medical Techology Co., Ltd. |
| K202954 | 2021-07-02 | FXX | Traditional | Xiamen Probtain Medical Techology Co., Ltd. |
| K201893 | 2020-12-09 | FXX | Traditional | Xiamen Probtain Medical Techology Co., Ltd. |
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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