FDA Registration
Active
🇫🇷 France
STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY SIDE FIRE PROBE (v3.3)
Reg #: 3011274144
·
FEI: 3011274144
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WESTLAKE PLASTICS EUROPE
- Registration Number
- 3011274144
- FEI Number
- 3011274144
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 rue de Maestricht
- City
- TOURCOING Nord
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K171040
Owner / Operator
- Firm Name
- WESTLAKE PLASTICS EUROPE
- Operator Number
- 10048274
- Address
- 2 rue de Maestricht
- City
- TOURCOING
- State
- Nord
- Postal Code
- 59200
- Country
- FR
US Agent
- Business Name
- Westlake Plastics Company
- Contact Name
- Yared Mengistu
- Address
- 490 W. Lenni Road
- City
- Lenni
- State
- PA
- ZIP
- 19052
- Country
- US
- [email protected]
- Phone
- 610 4591000 ext. 2326
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-04-07 |
Proprietary Names
STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY SIDE FIRE PROBE (v3.3)
LIN LEAD 14G or LIN LEAD 18G
NAIL 14G
PERINE GRID 14G
PERINE FULL GRID 14G
PERINE GRID 18G
STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY END FIRE PROBE (v3.2)
STEADY PRO SUPPORT FOR FULL 3D ENDOCAVITY SIDE FIRE PROBE (v3.2)
PERINE NAIL 14G or PERINE NAIL 18G
CON LEAD 14G or CON LEAD 18G
PERINE FULL GRID 18G
NAIL 18G
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)