Sterivic Medical Co., Ltd.
Registered establishment in Chizhou, Anhui, China. 3 device types, 1 clearance.
Sterivic Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Wrap, Sterilization, Absorber, Saliva, Paper and 1 other device type. Its earliest product listing with the FDA dates from 2026.
3device types registered with the FDA
1510(k) clearance
Registration
| Registered name | STERIVIC MEDICAL CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017113900 |
| FEI number | 3017113900 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 安徽宜人医用包装有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Chizhou |
|---|---|
| Province | Anhui |
| Address | DaDuKou Economic Development Zone |
| Postal code | 247210 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Dental Bibs | 2026 | 86 |
| Indicator, Physical/Chemical Sterilization Process | Class 2 | Sterilization Pouch/Roll | 2026 | 19 |
| Wrap, Sterilization | Class 2 | Sterilization Pouch/Roll | 2026 | 38 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251347 | 2026-01-28 | FRG | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Factory area | 14,200 m² (8 acres total) |
| Main products | Sterilization packaging, Sterilization wrapping, Sterilization monitoring, Medical dialyzing paper, Flexible composite film |
| Certifications | FDA 510K, ISO13485, ISO9001, CE, FSC, EUDR, PPWR |
| Export markets | 80+ countries |
| OEM and ODM | Offered |
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.