Marlen Mfg. & Development Co.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000055888 FEI 1520020
- Devices
- 176
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
UltraMax Ref 115232
UltraMax Ref 593422
UltraMax Ref 593812
UltraMax Ref 593534
UltraMax Ref 595922
UltraMax Ref 595522
UltraMax Gemini Ref 21029
UltraMax Gemini Ref 21000
UltraMax Ref 595634
UltraMax Ref 595612
UltraMax Ref 595534
UltraMax Ref 115229
UltraMax Ref 595819
UltraMax Ref 593244
UltraMax Ref 593138
UltraMax Ref 595644
UltraMax Ref 595844
UltraMax Ref 593425
UltraMax Ref 115519
UltraMax Ref 115538
UltraMax Ref 115844
UltraMax Ref 595638
UltraMax Ref 593725
UltraMax Ref 595238
UltraMax Gemini Ref 20038
UltraMax Ref 593838
UltraMax Ref 593238
UltraMax Ref 595929
UltraMax Ref 595813
UltraMax Ref 593834
UltraMax Gemini Ref 25300
Ostomy Belts Ref 590862
UltraMax Ref 595632
UltraMax Ref 593132
UltraMax Ref 593825
UltraMax Ref 593432
UltraMax Ref 595619
UltraMax Ref 595822
UltraMax Ref 593544
UltraMax Ref 595829
MiniMax Ref 53700
UltraMax Ref 593522
UltraMax Ref 593122
UltraMax Gemini Ref 21032
UltraMax Ref 595544
UltraMax Ref 595538
UltraMax Ref 593813
UltraMax Ref 593512
UltraMax Ref 115834
UltraMax Ref 595529
Showing 1-50 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 protected]
- PRRC contact
- Rik Smits
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.
Frequently asked questions
How many devices does Marlen Mfg. & Development Co. have in the registry?
The registry currently lists 176 devices for Marlen Mfg. & Development Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Marlen Mfg. & Development Co.'s devices?
Among its 50 most recently registered devices, Marlen Mfg. & Development Co. has devices listed in EUDAMED (50 devices).
What risk classes do Marlen Mfg. & Development Co.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Marlen Mfg. & Development Co.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Marlen Mfg. & Development Co. in the registry?
The most recently registered devices listed for Marlen Mfg. & Development Co. include UltraMax, UltraMax Gemini, Ostomy Belts and MiniMax.