FDA Registration
Active
🇺🇸 United States
MARLEN MFG. & DEVELOPMENT CO.
Reg #: 1520020
·
FEI: 1520020
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- MARLEN MFG. & DEVELOPMENT CO.
- Registration Number
- 1520020
- FEI Number
- 1520020
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5150 RICHMOND RD.
- City
- BEDFORD
- State
- OH
- ZIP
- 44146
- Country
- US
Owner / Operator
- Firm Name
- MARLEN MFG. & DEVELOPMENT CO.
- Operator Number
- 1520020
- Address
- 5150 RICHMOND RD., --
- City
- Bedford
- State
- OH
- Postal Code
- 44146
- Country
- US
- Correspondent
- GARY H FENTON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2007-11-28 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 2007-11-28 |
| Rod, Colostomy | EZP | Class 2 | Gastroenterology, Urology | No | 2007-11-28 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 1992-11-21 |
| Appliance, Colostomy, Disposable | EZS | Class 1 | Gastroenterology, Urology | No | 1977-12-21 |
Proprietary Names
Marlen Biliary Drainage Kit
Marlen "Adjust-A-Flo"
Loop Ostomy Rod
BEDSIDE DRAINBAG KIT
BEDSIDE DRAIN BAG KIT
MARLEN COLOSTOMY AP
Establishment Types
Manufacture Medical Device