Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043105166

FEI Number

3043105166

Entity Name

BAODING ABIORES CHIP CO., LTD.

City/State/Country

Baoding Hebei, CN

Establishment Address

3/F, Block B, Rongyi International Industrial Park, Dongjinzhuang Town, Lianchi District, Baoding Hebei 071066, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Baoding Abiores Chip Co., Ltd. (Owner Number: 10093832)

Owner / Operator Contact Address

3/F, Block B, Rongyi International Industrial Park, Dongjinzhuang Town, Lianchi District, Baoding, CN-HE 071066, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CorDx Tyfast Ovulation Test Cassette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2025-12-10

Official Correspondent

Connie Nie

US Agent Details

Vicky Huang Business: CorDx, Inc. Email: 6509@coretests.com Phone: (858) 8886916

Related Public Records

Same Entity

Baoding Abiores Chip 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-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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3013885851	CENTUM ELECTRONICS LIMITED	Bangalore Karnataka, IN
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043105166. Last updated year: 2026. Please use registration number 3043105166 when referencing this establishment in official correspondence.