Unisource Shanghai Ltd.
Registered establishment in Shanghai, China. 23 device types.
Unisource Shanghai Ltd. is a reprocessor holding a current FDA establishment registration. The registration covers Cotton, Roll, Cap, Surgical and 21 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | UNISOURCE SHANGHAI LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007165189 |
| FEI number | 3007165189 |
| Establishment type | Reprocessor, Repacker / relabeller, Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Bldg.#2, ROOM 802 Huayi Building |
| Postal code | 200235 |
| Country | China |
What It Makes
Clearances
No clearance names Unisource Shanghai Ltd. as applicant. One is 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 |
|---|---|---|---|---|
| K063666 | 2007-01-25 | MMK | Traditional | Biodex Medical Systems, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | Toothbrushes, Dental floss, Dental accessories, Medical disposables |
| Certifications | FDA, BSCI, ISO13485, FSC |
| Export markets | Dental clinics, promotional gifts, supermarkets |
| OEM and ODM | Offered |
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.