FDA Registration
Active
🇳🇱 Netherlands
ReCross
Reg #: 3007740583
·
FEI: 3007740583
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IMDS Operations B.V.
- Registration Number
- 3007740583
- FEI Number
- 3007740583
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ceintuurbaan Noord 150
- City
- Roden Groningen
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K210431
Owner / Operator
- Firm Name
- IMDS Operations B.V.
- Operator Number
- 10029918
- Address
- Ceintuurbaan Noord 150
- City
- Roden
- State
- Drenthe
- Postal Code
- 9301NZ
- Country
- NL
- Correspondent
- Edwin A Schulting
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- 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 |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-08-02 |
Proprietary Names
ReCross
Establishment Types
Manufacture Medical Device