FDA Registration
Active
🇳🇱 Netherlands
D466696 Radiation therapy marking device
Reg #: 3008574006
·
FEI: 3008574006
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PROMOLDING BV
- Registration Number
- 3008574006
- FEI Number
- 3008574006
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Laan van Ypenburg 108
- City
- Den Haag Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- DEN200041
Owner / Operator
- Firm Name
- Promolding BV
- Operator Number
- 10084363
- Address
- Laan van Ypenburg 108
- City
- Den Haag
- State
- Zuid-Holland
- Postal Code
- 2497 GC
- Country
- NL
- Correspondent
- Jac Gofers
US Agent
- Business Name
- FDABasics LLC
- Contact Name
- Jerry Doane
- Address
- 15815 Sw 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiation Therapy Marking Device | QRN | Class 2 | Radiology | No | 2022-02-14 |
Proprietary Names
D466696 Radiation therapy marking device
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)