Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043088157

FEI Number

3043088157

Entity Name

NINGBO CHIWELL BIOTECHNOLOGY CO.,LTD

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

3F, Building 18, Zone A, No.68 Yuhai East Road. Qianwan New District, (Digital Economy Industrial Park), Ningbo Zhejiang 315300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Ningbo chiwell Biotechnology Co.,Ltd (Owner Number: 10094520)

Owner / Operator Contact Address

3F, Building 18, Zone A, No.68 Yuhai East Road. Qianwan New District, (Digital Economy Industrial Park), Ningbo, CN-ZJ 315300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

All-in-one Automatic Slide Stainer & Cover-Slipper, Automatic Cover-slipper, Automatic Slide Stainer Formalin Substitute

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	2025-12-04
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2025-12-08

Official Correspondent

JUN LI

US Agent Details

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

Related Public Records

Same Entity

Ningbo chiwell Biotechnology 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 3043088157. Last updated year: 2026. Please use registration number 3043088157 when referencing this establishment in official correspondence.