FDA Registration
Active
🇳🇱 Netherlands
SEVENGROUND TRADING B.V.
Reg #: 3014015501
·
FEI: 3014015501
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- SEVENGROUND TRADING B.V.
- Registration Number
- 3014015501
- FEI Number
- 3014015501
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Amstelwijckweg 15
- City
- Dordrecht Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K172627
Owner / Operator
- Firm Name
- Sevenground Trading B.V.
- Operator Number
- 10055925
- Address
- Amstelwijckweg 15
- City
- Dordrecht
- State
- Zuid-Holland
- Postal Code
- NL-3316 BB
- Country
- NL
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2019-08-09 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2019-08-09 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-11-03 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-04-17 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-08-01 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2020-01-22 |
Proprietary Names
FK-127-co
FK-127-Co
DTR-1221-US-BLU
DT-R1221B
iProven Digital Thermometer DT-R1221A
DTR-1221-US-P
DTR-1221-US-BG
DTR-1221-US-BGW
Ankle Brace
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility