FDA Registration
Active
🇳🇱 Netherlands
Dynatron SmarTRAC
Reg #: 3004491421
·
FEI: 3004491421
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AIM B.V.
- Registration Number
- 3004491421
- FEI Number
- 3004491421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Boschstraat 6
- City
- Brunssum Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K151640
Owner / Operator
- Firm Name
- AIM B.V.
- Operator Number
- 10046555
- Address
- Boschstraat 6
- City
- Brunssum
- State
- NL-NOTA
- Postal Code
- 6442 PB
- Country
- NL
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Equipment, Traction, Powered | ITH | Class 2 | Physical Medicine | No | 2016-08-25 |
Proprietary Names
Dynatron SmarTRAC
Eltrac 471
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)