FDA Registration
Active
🇷🇴 Romania
MEMOSIL
Reg #: 3011203516
·
FEI: 3011203516
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Kulzer SRL
- Registration Number
- 3011203516
- FEI Number
- 3011203516
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Claderia C3, Dietrich Honold 1
- City
- Sacalaz-Judet Timis
- Country
- RO
Regulatory Submissions
- 510(k) Number
- K913537
Owner / Operator
- Firm Name
- KULZER, LLC
- Operator Number
- 9056636
- Address
- 4315 S. Lafayette Blvd.
- City
- South Bend
- State
- IN
- Postal Code
- 46614
- Country
- US
- Correspondent
- David A Vincent
US Agent
- Business Name
- Kulzer, LLC
- Contact Name
- David Vincent
- Address
- 4315 S Lafayette Blvd
- City
- South Bend
- State
- IN
- ZIP
- 46614
- Country
- US
- [email protected]
- Phone
- 574 2995421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2013-04-11 |
Proprietary Names
MEMOSIL
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)