Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026886124

FEI Number

3026886124

Entity Name

ROCGENE(XUZHOU) TECHNOLOGY LIMITED

City/State/Country

Xuzhou Jiangsu, CN

Establishment Address

Second Floor, Phase 1,Building 6, No. 10 Zhujiang East Road, Third Industrial Park, Xuzhou High-tech Industrial Development Zone, Xuzhou Jiangsu 221100, CN

Establishment Type(s)

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

Owner / Operator

RocGene(Xuzhou) Technology Limited (Owner Number: 10087522)

Owner / Operator Contact Address

Second Floor, Phase 1,Building 6, No. 10 Zhujiang East Road, Third Industrial Park, Xuzhou High-tech Industrial Development Zone, Xuzhou, CN-JS 221100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Real-Time PCR System (Model:Archimed X4 , Archimed X6), Real-Time PCR System (Model:Archimed Mini 16) Full-Automatic Nucleic Acid Detection and Analyzer Real-Time PCR System (Model:Archimed Mini Pro) Real-Time PCR System (Model: Archimed 384S/S-T)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-03-10

Official Correspondent

Ping Li

US Agent Details

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

Related Public Records

Same Entity

RocGene(Xuzhou) Technology Limited

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 3026886124. Last updated year: 2026. Please use registration number 3026886124 when referencing this establishment in official correspondence.