Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030040496

FEI Number

3030040496

Entity Name

CHANGSHA YINGTAI INSTRUMENT CO., LTD

City/State/Country

changsha city Hunan, CN

Establishment Address

Room 101, Building 2, No. 777, Yangjiawan Road, Wangcheng Economic and Technological Development zone, changsha city Hunan 410200, CN

Establishment Type(s)

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

Owner / Operator

Changsha Yingtai Instrument Co., Ltd (Owner Number: 10089044)

Owner / Operator Contact Address

Room 101, Building 2, No. 777, Yangjiawan Road, Wangcheng Economic and Technological Development Zone, Changsha City, CN-HN 410200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MP14,MP16,MP18,MP20,RT-500 SH7006,SH9006,SH9009,RT-320,MP2,MP5,MP8,MP12, Freeze Dyrer ST7003,ST7006,ST9006,SF7009,SF9009,SF7012,SF9012, iSeal-410, iSeal-420; iSeal-500, iSeal-510, iSeal-520 Tube Sealer iSeal-130,iSeal-140,Iseal-230,Iseal-240 iSeal-220; iSeal-300, iSeal-310, iSeal-320; iSeal-400, iseal-100, iSeal-110, iSeal-120; iSeal-200, iSeal-210, THR16E;TD5J,TD5E,TDL5E. Vacuum Centrifugal Concentrator: SD-25,SD-25C, SD-33,SD-33C Cytoprep-1,Cytoprep-2,TG18A;TDL6,TDL6F,TD5H,TD5I;TG16E;TG20,TDL5,TDL5A, TDL5M,TGL16E,TGL16,TGL20,TGL18, DDL6,DL6MB,CDL7M,DL8M,GL12,GL21M,GL10,DD6,DD5,DDL5,TG16; Centrifuge: TD4C,TD4A,TD4B,TD4N,TD5,TD5A,TD5B,TD4,TXK4,TD6,TD6C,TGM12,TGW16, 0.2ml,0.5ml,1ml,1.5ml,2ml, 5ml,7ml,10ml,15ml,20ml,30ml,25ml,30ml,50ml,85ml,100ml, 250ml,500ml,1000ml,800ml Plastic tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-12-22
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	2024-12-22
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2023-10-31
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-10-31

Official Correspondent

Yu Zhou

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

Changsha Yingtai Instrument Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030040496. Last updated year: 2026. Please use registration number 3030040496 when referencing this establishment in official correspondence.