Changshu Rozer Irradiation Technology Co., Limited
Registered establishment in Changshu, Jiangsu, China. 2 device types.
Changshu Rozer Irradiation Technology Co., Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Container, Specimen, Sterile, Tube, Collection, Capillary Blood. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | CHANGSHU ROZER IRRADIATION TECHNOLOGY CO., LIMITED. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3030530726 |
| FEI number | 3030530726 |
| Establishment type | Contract manufacturer, Contract steriliser |
Location
| City | Changshu |
|---|---|
| Province | Jiangsu |
| Address | No.10, Xingde Road, Shajiabang Town |
| Postal code | 215500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Container, Specimen, Sterile | Class 1 | 2025 | 79 | |
| Tube, Collection, Capillary Blood | Class 1 | Tube, Collection, Capillary Blood | 2024 | 16 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Sterilization services for medical devices, Ethylene oxide sterilization |
| Certifications | ISO13485-2016, ISO11135-2014, FDA registered |
| Export markets | Works with 7 of world’s top 10 medical equipment enterprises |
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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