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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 2 of 4

  • UltraMax Ref 115832

    Class I EUDAMED Active

  • UltraMax Ref 593429

    Class I EUDAMED Active

  • UltraMax Ref 593732

    Class I EUDAMED Active

  • UltraMax Ref 595944

    Class I EUDAMED Active

  • UltraMax Ref 593212

    Class I EUDAMED Active

  • UltraMax Ref 593134

    Class I EUDAMED Active

  • Ultra Max Ref 595212

    Class I EUDAMED Active

  • UltraMax Ref 595229

    Class I EUDAMED Active

  • UltraMax Ref 593222

    Class I EUDAMED Active

  • UltraMax Gemini Ref 20029

    Class I EUDAMED Active

  • MiniMax Ref 53800

    Class I EUDAMED Active

  • UltraMax Ref 595232

    Class I EUDAMED Active

  • UltraMax Gemini Ref 21034

    Class I EUDAMED Active

  • UltraMax Ref 593819

    Class I EUDAMED Active

  • UltraMax Ref 115812

    Class I EUDAMED Active

  • UltraMax Ref 115522

    Class I EUDAMED Active

  • UltraMax Ref 595912

    Class I EUDAMED Active

  • UltraMax Ref 595234

    Class I EUDAMED Active

  • UltraMax Ref 593119

    Class I EUDAMED Active

  • UltraMax Ref 595625

    Class I EUDAMED Active

  • UltraMax Ref 595938

    Class I EUDAMED Active

  • UltraMax Ref 595919

    Class I EUDAMED Active

  • UltraMax Ref 115222

    Class I EUDAMED Active

  • UltraMax Ref 593438

    Class I EUDAMED Active

  • UltraMax Ref 593712

    Class I EUDAMED Active

  • MiniMax Ref 53600

    Class I EUDAMED Active

  • UltraMax Ref 115829

    Class I EUDAMED Active

  • UltraMax Ref 595834

    Class I EUDAMED Active

  • UltraMax Ref 595532

    Class I EUDAMED Active

  • UltraMax Ref 115234

    Class I EUDAMED Active

  • UltraMax Ref 593738

    Class I EUDAMED Active

  • UltraMax Gemini Ref 25200

    Class I EUDAMED Active

  • UltraMax Ref 115529

    Class I EUDAMED Active

  • UltraMax Gemini Ref 21019

    Class I EUDAMED Active

  • UltraMax Ref 593219

    Class I EUDAMED Active

  • UltraMax Ref 593225

    Class I EUDAMED Active

  • UltraMax Ref 115825

    Class I EUDAMED Active

  • UltraMax Ref 115822

    Class I EUDAMED Active

  • UltraMax Ref 595519

    Class I EUDAMED Active

  • UltraMax Ref 115219

    Class I EUDAMED Active

  • UltraMax Ref 595832

    Class I EUDAMED Active

  • UltraMax Ref 115238

    Class I EUDAMED Active

  • UltraMax Ref 595838

    Class I EUDAMED Active

  • UltraMax Ref 595280

    Class I EUDAMED Active

  • UltraMax Ref 595344

    Class I EUDAMED Active

  • MaxSeal Ref 9700

    Class I EUDAMED Active

  • UltraMax Ref 115225

    Class I EUDAMED Active

  • SuperFlat Ref 596512

    Class I EUDAMED Active

  • SuperFlat Ref 596312

    Class I EUDAMED Active

  • UltraMax Ref 593234

    Class I EUDAMED Active

Showing 51-100 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
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.