Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012727921

FEI Number

3012727921

Entity Name

HUA CHENG XIN PLASTIC MOLD CO. LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

BUILDING 71, REN TIAN COMMUNITY INDUSTRIAL ZONE,, FUHAI, BAO AN DISTRICT, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hua Cheng Xin Plastic Mold Co. Ltd. (Owner Number: 10052424)

Owner / Operator Contact Address

BUILDING 71, REN TIAN COMMUNITY INDUSTRIAL ZONE,, FUHAI, BAO AN DISTRICT, SHENZHEN, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2016-07-27
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2019-11-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2018-08-10
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2016-07-27

Official Correspondent

No official correspondent registered.

US Agent Details

Erin St. Onge Business: Simport, Director of Sales and Business Development Email: erin.stonge@simport.com Phone: (843) 8226495

Related Public Records

Same Entity

Hua Cheng Xin Plastic Mold 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 3012727921. Last updated year: 2026. Please use registration number 3012727921 when referencing this establishment in official correspondence.