Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2029011

FEI Number

1000160571

Entity Name

ROLENN MANUFACTURING, INC.

City/State/Country

Riverside, CA, US

Establishment Address

1549 Marlborough Ave, Riverside, CA 92507, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Rolenn Manufacturing, Inc. (Owner Number: 10094188)

Owner / Operator Contact Address

1549 Marlborough Avenue, Riverside, CA 92507, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FUJIFILM Distal End Cap, DC-08D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-11-18

Official Correspondent

Justin Hatcher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rolenn Manufacturing, Inc.

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
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11

Similar Registrations

Registration Number	Establishment Name	Location
3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
3008386005	IAN JAMIESON PTY LTD	Fyshwick Australian Capital Territory, AU
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
9610595	AIZU OLYMPUS CO., LTD.	AIZUWAKAMATSU-SHI Fukushima, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029011. Last updated year: 2026. Please use registration number 2029011 when referencing this establishment in official correspondence.