Medical Enterprises Europe B.V.
NL-MF-000019133 · Netherlands · Amstelveen
Medical Enterprises Europe B.V. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 1 |
|---|---|
| Class IIb | 4 |
Most frequent device types declared: CDS932B, LI932B, LI932B-S, SB-TS 101.2, SB-TS 101.3.
Among these devices, 3 are declared sterile, 4 active, 2 with a measuring function.
Devices declared under this manufacturer
- Closed Drainage Set Bag
- SB-TS 101.2
- Synergo® System
- Transurethral RF Ablation Applicator
- Tubing-line disposable set
Catalogue references include CDS932B, LI932B, LI932B-S, SB-TS 101.2, SB-TS 101.3.
European nomenclature codes declared: Z12169085, Z12169080.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| 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. Medical Enterprises Europe B.V. was not found in either the U.S. or the Canadian register.