Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027605723

FEI Number

3027605723

Entity Name

Hangzhou Diagens Biotechnology Co., Ltd.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 101, Building 1, No. 609 Hongfeng Road, Donghu Subdistrict, Linping District, Hangzhou Zhejiang 311103, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hangzhou Diagens Biotechnology Co., Ltd. (Owner Number: 10088245)

Owner / Operator Contact Address

Room 101, Building 1, No. 609 Hongfeng Road, Donghu Subdistrict, Linping District, Hangzhou, CN-ZJ 311103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Automatic microscopic image scanning system MetaSight DSL-A1 MetaSight DSL-G160 DSL-G8 DSL-G200 DSL-G80

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NVV	Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System	Clinical Chemistry	Class 1	862.2100	2023-06-16
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2024-12-24

Official Correspondent

chaoyu wu

US Agent Details

Zhang Heng Business: YOUKE E-COMMERCE INC Email: youkecommerce@hotmail.com Phone: (720) 7609666

Related Public Records

Same Entity

Hangzhou Diagens 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 3027605723. Last updated year: 2026. Please use registration number 3027605723 when referencing this establishment in official correspondence.