Hangzhou Healthsky Biotechnology Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 6 device types.
Hangzhou Healthsky Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Stain, Papanicolau, General Purpose Reagent and 4 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | HANGZHOU HEALTHSKY BIOTECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3038196622 |
| FEI number | 3038196622 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 杭州海世嘉生物科技有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 302, Building No 1, Room 201, Building No 1-1, No.2073, Jinchang Road, Liangzhu Street, Yuhang District |
| Postal code | 311100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | Class 1 | Cell Preservation Vial | 2025 | 115 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | Class 1 | Liquid-Based Cytology Processing Kit | 2025 | 7 |
| General Purpose Reagent | Class 1 | Fully Automated Liquid-Based Cytology Workstation | 2025 | 30 |
| Processor, Tissue, Automated | Class 1 | Automated Tissue Processing System | 2025 | 5 |
| Slide Stainer, Automated | Class 1 | Fully Automated Slide Sorter | 2025 | 14 |
| Stain, Papanicolau | Class 1 | Papanicolaou Stain Kit | 2025 | 4 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | Liquid-Based Cytology equipment, Tissue Processing Systems, Whole Slide Imaging System, Slide Printers, PATHO.AI diagnostic solution |
| Export markets | Asia, Europe, Middle East, Americas |
| 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.