Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016621374

FEI Number

3016621374

Entity Name

Jiangsu Medomics Medical Technology Co., Ltd.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

Building 01, Phase 6, No.71, Xinghui Road, Jiangbei New Area, Nanjing Jiangsu 210000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Medomics Medical Technology Co.,Ltd. (Owner Number: 10087833)

Owner / Operator Contact Address

Building 01, Phase 6, No.71, Xinghui Road, Jiangbei New Area, Nanjing, CN-JS 210000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medomics, Automated Stainer Medomics, Vaginal pH Test Kit, Model: 012144-01-352, 012144-02-352, 012144-05-352, 012144-20-352 Medomics, Fungal Fluorescent Staining Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2023-05-30
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2024-01-01
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2023-04-23

Official Correspondent

Han Fang

US Agent Details

Thomas Tang Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Jiangsu Medomics Medical Technology 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-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016621374. Last updated year: 2026. Please use registration number 3016621374 when referencing this establishment in official correspondence.