MARLEN MFG. & DEVELOPMENT CO.

FDA Device Registration & Listing · BEDFORD, OH, US · Registration 1520020

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1520020
FEI Number
1520020
Entity Name
MARLEN MFG. & DEVELOPMENT CO.
City/State/Country
BEDFORD, OH, US
Establishment Address
5150 RICHMOND RD., BEDFORD, OH 44146, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MARLEN MFG. & DEVELOPMENT CO. (Owner Number: 1520020)
Owner / Operator Contact Address
5150 RICHMOND RD., --, Bedford, OH 44146, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Marlen Biliary Drainage Kit Marlen "Adjust-A-Flo"

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2007-11-28
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 2007-11-28

Official Correspondent

GARY FENTON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MARLEN MFG. & DEVELOPMENT CO.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3030446844 PLATINUM FOCUS GROUP LTD. London London, City of, GB
2030624 Isomedix Operations, Inc. Temecula, CA, US
3004111573 Sterigenics US LLC Grand Prairie, TX, US
3033589330 Merit Medical Australia Pty Ltd. Braiside Victoria, AU
3011642792 Merit Maquiladora Mexico, S. DE R.L. DE C.V. Tijuana Baja California, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1520020. Last updated year: 2026. Please use registration number 1520020 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.