FDA Registration
Active
🇳🇱 Netherlands
Brachumera Sport
Reg #: 8030476
·
FEI: 1000601592
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LODE B.V.
- Registration Number
- 8030476
- FEI Number
- 1000601592
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ZERNIKEPARK 16
- City
- GRONINGEN
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K851097
Owner / Operator
- Firm Name
- LODE B.V.
- Operator Number
- 9019791
- Address
- ZERNIKEPARK 16, --
- City
- GRONINGEN
- State
- NL-NOTA
- Postal Code
- 9747 AN
- Country
- NL
- Correspondent
- Jan Reinder - Fransens
US Agent
- Business Name
- ElectraMed Corporation
- Contact Name
- Dana Burger-Dipzinski
- Address
- G-5332 Hill 23 Dr.
- City
- Flint
- State
- MI
- ZIP
- 48507
- Country
- US
- [email protected]
- Phone
- 800 6784856 ext. 4104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 1999-02-25 |
Proprietary Names
Brachumera Sport
Corival rehab
Angio imaging fixation set
Excalibur Sport PFM
Angio cpet - with static wall mount
Corival Pediatric
Angio rehab fixation set
Brachumera Sport PFM
Excalibur Sport
Angio cpet - with automatic stand
Angio rehab - static wall fixation
Corival Recumbent cpet
Angio imaging support radiology
Angio rehab
Corival OEM
Angio imaging support ultrasound
Corival cpet
Angio cpet - with electrical adjustable wall mount
Angio rehab electrical wall fix.
Angio cpet - single set
Corival Recumbent rehab
Establishment Types
Manufacture Medical Device