Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004052101

FEI Number

3004052101

Entity Name

Dalian Create Medical Products Co., LTD.

City/State/Country

Dalian Liaoning, CN

Establishment Address

No. IIB-31, Dalian Export Processing Zone,, Dalian Liaoning 116600, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dalian Create Medical Products Co., LTD. (Owner Number: 10094388)

Owner / Operator Contact Address

No. IIB-31, Dalian Export Processing Zone, Dalian, CN-LN 116600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tube Kit TY-500D Endoscope Model EN-580T Over-Tube TS-1314B Scope Balloon BS-4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-11-26
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Vader Business: FUJIFILM Healthcare Americas Corporation Email: randy.vader@fujifilm.com Phone: (360) 3566821

Related Public Records

Same Entity

Dalian Create Medical Products 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
K904800	Olympus Corp.	SIF-SW	1991-03-27
K233321	FUJIFILM Healthcare Americas Corporation	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	2024-06-13
K251204	FUJIFILM Healthcare Americas Corporation	FUJIFILM Stiffening Wire Device (SW-2000)	2025-09-26

Similar Registrations

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
3009698186	ACTUATED MEDICAL, INC.	Bellefonte, PA, US
9610595	AIZU OLYMPUS CO., LTD.	AIZUWAKAMATSU-SHI Fukushima, JP
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP
3042225166	FUJIFILM Corporation Medical Systems Research & Development Center Kaisei	Ashigarakami-Gun Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004052101. Last updated year: 2026. Please use registration number 3004052101 when referencing this establishment in official correspondence.