Marlen Mfg. & Development Co.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000055888 FEI 1520020

Devices: 176
Registrations: EUDAMEDFDA
FDA recalls: 0

Catalogue176

Newest first, page 4 of 4

UltraMax Ref 593525

Class I EUDAMED Active
UltraMax Ref 595325

Class I EUDAMED Active
SuperFlat Ref 596212

Class I EUDAMED Active
UltraMax Gemini Ref 21038

Class I EUDAMED Active
UltraMax Ref 115212

Class I EUDAMED Active
MaxSeal Ref 9800

Class I EUDAMED Active
UltraMax Ref 115525

Class I EUDAMED Active
UltraMax Ref 593734

Class I EUDAMED Active
UltraMax Ref 593419

Class I EUDAMED Active
UltraMax Ref 593519

Class I EUDAMED Active
UltraMax Ref 595512

Class I EUDAMED Active
UltraMax Gemini Ref 20025

Class I EUDAMED Active
UltraMax Ref 593232

Class I EUDAMED Active
UltraMax Ref 115838

Class I EUDAMED Active
UltraMax Ref 593532

Class I EUDAMED Active
Ultra Max Ref 595312

Class I EUDAMED Active
UltraMax Ref 595825

Class I EUDAMED Active
MegaMax Ref 595200

Class I EUDAMED Active
UltraMax Ref 593713

Class I EUDAMED Active
UltraMax Ref 593729

Class I EUDAMED Active
UltraMax Ref 593719

Class I EUDAMED Active
UltraMax Ref 115512

Class I EUDAMED Active
UltraMax Ref 593844

Class I EUDAMED Active
UltraMax Ref 595934

Class I EUDAMED Active
UltraMax Ref 115532

Class I EUDAMED Active
Marlen Ultra Ileostomy Pouch-5000 Ref K880327

Class I FDA 510(k) Active

Showing 151-176 of 176

Company details

EUDAMED SRN: US-MF-000055888
FDA FEI number: 1520020
EUDAMED status: Active
EUDAMED registered name: Marlen Mfg. & Development Co.
EUDAMED abbreviated name: Marlen
Registered address: 5150, Richmond Road, 44146, Bedford, United States
Email: [email protected]
PRRC contact: Rik Smits(public in EUDAMED)

What Marlen Mfg. & Development Co. makes

Marlen Mfg. & Development Co. manufactures ostomy pouches, including the UltraMax and MARLEN ULTRA ILEOSTOMY POUCH-5000 models.

The company's products are Class I devices and are listed in both the EU's EUDAMED and the FDA's 510(k) registry. Marlen Mfg. & Development Co. is based in the US.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue176

UltraMax Ref 593525

UltraMax Ref 595325

SuperFlat Ref 596212

UltraMax Gemini Ref 21038

UltraMax Ref 115212

MaxSeal Ref 9800

UltraMax Ref 115525

UltraMax Ref 593734

UltraMax Ref 593419

UltraMax Ref 593519

UltraMax Ref 595512

UltraMax Gemini Ref 20025

UltraMax Ref 593232

UltraMax Ref 115838

UltraMax Ref 593532

Ultra Max Ref 595312

UltraMax Ref 595825

MegaMax Ref 595200

UltraMax Ref 593713

UltraMax Ref 593729

UltraMax Ref 593719

UltraMax Ref 115512

UltraMax Ref 593844

UltraMax Ref 595934

UltraMax Ref 115532

Marlen Ultra Ileostomy Pouch-5000 Ref K880327

Company details

What Marlen Mfg. & Development Co. makes