Oldelft Benelux B.V.
NL-MF-000005892 · Netherlands · Veenendaal
Oldelft Benelux B.V. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 6 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- Easy DR
- Easy DR plus
- LLS-1-410
- LLS-1-710
- Stand Easy DR (145 version, rotation)
- Stand Easy DR Plus (183 version, non-rotation)
- Stitch Frame U
- Stitch Frame U with tilting patient step
Catalogue references include 044H07200, 044H07292, 044I00607, LLS-1-yyyy-xxxx, SF-U-yyyy-xxxx, THOxxxx.
European nomenclature codes declared: Z11079080, Z11039012, Z11079007, Z12011280.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Oldelft Benelux B.V. was not found in either the U.S. or the Canadian register.