FDA Registration
Active
🇨🇳 China
HANGZHOU HEALTHSKY BIOTECHNOLOGY CO., LTD.
Reg #: 3038196622
·
FEI: 3038196622
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- HANGZHOU HEALTHSKY BIOTECHNOLOGY CO., LTD.
- Registration Number
- 3038196622
- FEI Number
- 3038196622
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 302, Building No 1, Room 201, Building No 1-1, No.2073, Jinchang Road, Liangzhu Street, Yuhang District
- City
- Hangzhou City Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Hangzhou HealthSky Biotechnology Co., Ltd.
- Operator Number
- 10093073
- Address
- Room 302, Building No 1, Room 201, Building No 1-1, No.2073, Jinchang Road, Liangzhu Street, Yuhang District
- City
- Hangzhou City
- State
- Zhejiang
- Postal Code
- 311100
- Country
- CN
- Correspondent
- Shanghua Yao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2025-03-26 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2025-03-26 |
| Stain, Papanicolau | HZJ | Class 1 | Hematology | No | 2025-03-26 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | Class 1 | Pathology | No | 2025-03-26 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2025-03-26 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2025-03-26 |
Proprietary Names
Fully Automated Liquid-Based Cytology Workstation
Automated Tissue Processing System
Papanicolaou Stain Kit
Liquid-Based Cytology Processing Kit
Cell Preservation Vial
Fully Automated Slide Sorter
Establishment Types
Manufacture Medical Device