HANGZHOU HEALTHSKY BIOTECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Hangzhou City Zhejiang, CN · Registration 3038196622

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038196622
FEI Number
3038196622
Entity Name
HANGZHOU HEALTHSKY BIOTECHNOLOGY CO., LTD.
City/State/Country
Hangzhou City Zhejiang, CN
Establishment Address
Room 302, Building No 1, Room 201, Building No 1-1, No.2073, Jinchang Road, Liangzhu Street, Yuhang District, Hangzhou City Zhejiang 311100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hangzhou HealthSky Biotechnology Co., Ltd. (Owner Number: 10093073)
Owner / Operator Contact Address
Room 302, Building No 1, Room 201, Building No 1-1, No.2073, Jinchang Road, Liangzhu Street, Yuhang District, Hangzhou City, CN-ZJ 311100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPM General Purpose Reagent Pathology Class 1 864.4010 2025-03-26
IEO Processor, Tissue, Automated Pathology Class 1 864.3875 2025-03-26
HZJ Stain, Papanicolau Hematology Class 1 864.1850 2025-03-26
MXT Device, Accessory, Cooling Plate For Tissue Embedding Station Pathology Class 1 864.3010 2025-03-26
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2025-03-26
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2025-03-26

Official Correspondent

Shanghua Yao

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hangzhou HealthSky Biotechnology Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038196622. Last updated year: 2026. Please use registration number 3038196622 when referencing this establishment in official correspondence.
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