Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012942167

FEI Number

3012942167

Entity Name

HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO., LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

No.35, Jinsui Road, Wangcheng Economic Development Zone, Changsha Hunan 410200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO., LTD (Owner Number: 10090859)

Owner / Operator Contact Address

No.35, Jinsui Road, Wangcheng Economic Development Zone, Changsha, CN-HN 410200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blood Bank Centrifuge Centrifuge for preparation of cell concentrate and/or plasma concentrate Incubator CYTO Centrifuge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	2024-05-23
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate	Clinical Chemistry	Class 1	862.2050	2024-05-23
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2024-05-23
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2024-05-23

Official Correspondent

Wenjiao Zhou

US Agent Details

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

Related Public Records

Same Entity

HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT 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 3012942167. Last updated year: 2026. Please use registration number 3012942167 when referencing this establishment in official correspondence.