FDA Registration
Active
🇳🇱 Netherlands
LODE B.V.
Reg #: 8030476
·
FEI: 1000601592
·
Expires 2026
Products
4
Proprietary Names
33
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- LODE B.V.
- Registration Number
- 8030476
- FEI Number
- 1000601592
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZERNIKEPARK 16
- City
- GRONINGEN
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K202979
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 | 2021-11-12 |
| Treadmill, Powered | IOL | Class 1 | Physical Medicine | No | 2009-05-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2009-05-13 |
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2009-05-13 |
Proprietary Names
Valiant 2 cpet
Valiant 2 cpet XL
Katana sport
Valiant 2 rehab XL
Flow cpet
Katana sport XL
Valiant 2 sport XL
Valiant 2 pediatric
Valiant 2 sport
Valiant 2 OEM
Flow rehab
Valiant 2 rehab
Angio cpet - with electrical adjustable wall mount
Angio rehab electrical wall fix.
Corival Recumbent cpet
Angio imaging support ultrasound
Excalibur Sport PFM
Brachumera Sport
Corival rehab
Brachumera Sport PFM
Angio rehab
Angio imaging fixation set
Angio cpet - single set
Corival OEM
Angio cpet - with static wall mount
Angio rehab fixation set
Corival Recumbent rehab
Angio imaging support radiology
Excalibur Sport
Angio cpet - with automatic stand
Corival Pediatric
Corival cpet
Angio rehab - static wall fixation
Establishment Types
Manufacture Medical Device