Lode B.V.
NL-MF-000001493 · Netherlands · Groningen
Lode B.V. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 9 |
|---|
Among these devices, 9 are declared active, 9 with a measuring function.
Devices declared under this manufacturer
- Excalibur Sport
- Excalibur Sport + BPM
- Excalibur Sport + BPM + SpO2
- Excalibur Sport + SpO2
- Excalibur Sport PFM
- Excalibur Sport PFM + BPM
- Excalibur Sport PFM + BPM + SpO2
- Excalibur Sport PFM + SpO2
- Lode ECG Streamer
Catalogue references include 950920, 965910, 965910B, 965910S, 965910SB, 965920B.
European nomenclature codes declared: Z12050101, Z129003, Z12050301.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LODE B.V. (NL) · FDA 8030476 |
| Devices in EUDAMED | 9 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LODE B.V. |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2025-06-13 |
Licence types: Device Family (2).
Licensed under: TREADMILL, ERGOMETER.
North American profile: Both markets. Lode B.V. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2246826CE01 | supplemented | 2027-01-01 |