Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 2 device types.
Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Alarm, Conditioned Response Enuresis, Stimulator, Transcutaneous Electrical, Aesthetic Purposes. Its earliest product listing with the FDA dates from 2022.
Registration
| Registered name | ROSTI INTEGRATED MANUFACTURING SOLUTIONS (SUZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017133271 |
| FEI number | 3017133271 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No.1 HuaZheng Street, Suzhou Industrial Park |
| Postal code | 215028 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Alarm, Conditioned Response Enuresis | Class 2 | Tena Smart Care | 2022 | 4 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Class 2 | Nu Skin RenuSpa iO | 2023 | 22 |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 800 |
|---|---|
| Factory area | 25,000 m² |
| Main products | precision plastic injection molded components, medical device manufacturing, multi-shot molded parts, secondary processes, contract assembly |
| Certifications | ISO 9001:2015, ISO 45001:2018, ISO 14001:2015, ISO 13485:2016, FSSC 22000, IATF 16949:2016, FDA, UL |
| Export markets | Medical, packaging, appliances, automation, automotive |
| 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.
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