FDA Registration
Active
🇫🇷 France
Isiris ?; Isiris Monitor; Isiris Monitor Fixture; Isiris Monitor adaptor kit type G; Isiris Monitor adaptor kit-typ
Reg #: 3012649202
·
FEI: 3012649202
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Centre de distribution Coloplast Le Plessis Pate
- Registration Number
- 3012649202
- FEI Number
- 3012649202
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Rue Jacqueline Auriol
- City
- Le Plessis-Pate Essonne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K160766
Owner / Operator
- Firm Name
- Coloplast Corp.
- Operator Number
- 8010144
- Address
- 1601 West River Road North
- City
- Minneapolis
- State
- MN
- Postal Code
- 55411
- Country
- US
US Agent
- Business Name
- COLOPLAST CORP
- Contact Name
- Brian Schmidt
- Address
- 1601 West River Road N
- City
- Minneapolis
- State
- MN
- ZIP
- 55411
- Country
- US
- [email protected]
- Phone
- 612 8651177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2017-03-02 |
Proprietary Names
Isiris ?; Isiris Monitor; Isiris Monitor Fixture; Isiris Monitor adaptor kit type G; Isiris Monitor adaptor kit-typ
Establishment Types
Export Device to the United States But Perform No Other Operation on Device