Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010684578

FEI Number

3010684578

Entity Name

NINGBO ICAN MACHINES CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No.77 Yunlin East Road, Gulin Town, Haishu District, Ningbo Zhejiang 315176, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ningbo Ican Machines Co., Ltd. (Owner Number: 10094502)

Owner / Operator Contact Address

No.77 Yunlin East Road, Gulin Town, Haishu District, Ningbo, CN-ZJ 315176, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243994

PMA Number

N/A

All Registered Proprietary Names

23D Pro 28D Pro Steam Sterilizer (2545D) 2545D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2025-12-04

Official Correspondent

Henry Lin

US Agent Details

Shan Liu Email: Yepdent@gmail.com Phone: (949) 7504444

Related Public Records

Same Entity

Ningbo Ican Machines Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

Similar Registrations

Registration Number	Establishment Name	Location
1219189	CONSOLIDATED MACHINE CORP.	Billerica, MA, US
3005899764	STERIS MEXICO, S. de R.L. de C.V.	GUADALUPE Nuevo Leon, MX
8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL
3022516928	DENT4YOU AG	Heerbrugg Sankt Gallen, CH
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010684578. Last updated year: 2026. Please use registration number 3010684578 when referencing this establishment in official correspondence.