Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010402964

FEI Number

3010402964

Entity Name

AIKANG MEDTECH CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

201, 3F&13F, Aikang Building 1, No.66 Juqing Rd, Jinsha Community of Kengzi, Pingshan District, Shenzhen Guangdong 518118, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AIKANG MEDTECH CO., LTD (Owner Number: 10044248)

Owner / Operator Contact Address

201, 3F&13F, Aikang Building 1, No.66 Juqing Rd, Jinsha Community of Kengzi, Pingshan District, Shenzhen, CN-GD 518118, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Automated liquid handling system : Uranus series, Xanuts series Automated blood component separator Nucleic Acid extracting system Automated Chemiluminescence Immunoassay System : Tethys series Automatic Elisa Analyzer : URANUS series Plasma Freezers : Oceanus series Automated Blood Grouping Analyzer : Metis series, Aigel series Large capacity refrigerated centrifuge High speed refrigerated centrifuge High speed centrifuge

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	2015-10-09
JJI	Analyzer, Enzyme, For Clinical Use	Clinical Chemistry	Class 1	862.2500	2013-05-16
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2015-10-09
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2013-05-16
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2015-10-09

Official Correspondent

Xueqin Wang

US Agent Details

Charles Shen Business: Manton Business and Technology Services LLC Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

AIKANG MEDTECH CO., LTD

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26

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 3010402964. Last updated year: 2026. Please use registration number 3010402964 when referencing this establishment in official correspondence.