Yian Medical Technology (Haining) Co., Ltd.
Manufacturer and brand owner in Jiaxing, Zhejiang, China. 1 device type, 2 products catalogued, 4 clearances.
Yian Medical Technology (Haining) Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers X-Ray, Tomography, Computed, Dental. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
1device type
2products catalogued under its own name
4510(k) clearances
Registration
| Registered name | YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3023322470 |
| FEI number | 3023322470 |
| DUNS | 713686549 |
| Establishment type | Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 奕安医疗科技（海宁）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Jiaxing |
|---|---|
| Province | Zhejiang |
| Address | 1st Floor Area 1,2nd Floor Area 1,Building A, No. 2 Caohejing Road, Haining Economic Development Zone, |
| Postal code | 314400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | Class 2 | OAS – X-ray, tomography, computed, dental, Dental CBCT X-ray System | 2024 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Yian Medical Technology (Haining) Co., Ltd. | IZL | 2 |
| Dental Cone-beam Computed Tomography | OAS | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251642 | 2025-06-27 | OAS | Special | This company |
| K240855 | 2024-04-25 | OAS | Special | This company |
| K232710 | 2024-01-09 | OAS | Traditional | This company |
| K220700 | 2022-05-04 | IZL | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2020 |
|---|---|
| Factory area | 8,000 m² |
| Main products | fixed DR systems, mobile DR systems, portable DR systems, C-arms, mammography systems, flat-panel CT |
| Certifications | ISO13485, CE MDR, Zhejiang High-tech Enterprise |
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.