FDA Registration
Active
🇮🇪 Ireland
FLOWASSIST Seal
Reg #: 3015332213
·
FEI: 3015332213
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- OSTOFORM LTD
- Registration Number
- 3015332213
- FEI Number
- 3015332213
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ostoform Limited, Unit 5C Fairgreen House, St. Lomans Terrace
- City
- Mullingar Westmeath
- Country
- IE
Owner / Operator
- Firm Name
- Ostoform Ltd
- Operator Number
- 10060178
- Address
- Ostoform Limited, Unit 5C Fairgreen House, St. Lomans Terrace
- City
- Mullingar
- State
- Westmeath
- Postal Code
- N91 H635
- Country
- IE
US Agent
- Business Name
- Ostoform Inc
- Contact Name
- Kevin Kelleher
- Address
- 200 E Main St Ste 910
- City
- Fort Wayne
- State
- IN
- ZIP
- 46802
- Country
- US
- [email protected]
- Phone
- 260 9016338
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2019-04-08 |
Proprietary Names
FLOWASSIST Seal
Ostoform FLOWASSIST Flat Baseplate
Ostoform FLOWASSIST Convex Baseplate
Ostoform Crest Moldable Barrier
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device