GENMED ENTERPRISES INTERNATIONAL LTD
GB-MF-000010687 · United Kingdom · Cadiff
GENMED ENTERPRISES INTERNATIONAL LTD is registered in the European database on medical devices as a manufacturer, with 280 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 280 |
|---|
Most frequent device types declared: TW/TO/TB/TWF/TOHF/GA Series.
Among these devices, 280 are declared sterile.
Authorised representative in the Union: GENMED ENTERPRISES MEDICAL LIMITED.
Devices declared under this manufacturer
- Sterile OBTURATOR for single use (Optical normal type)
- Sterile trocar for single use (Bladed Balloon ring fixation type) Dual
- Sterile trocars for single use (Bladeless FIXATION balloon type) Dual
- Sterile trocars for single use (Bladeless basic type)
- Sterile trocars for single use (Bladeless basic type) Dual pack
- Sterile trocars for single use (Cannula Balloon ring fixation type)
- Sterile trocars for single use (Hassan anchor fixation balloon type)
- Sterile trocars for single use (Optical Bladeless Balloon ring fixatio
- Sterile trocars for single use (Optical FIXATION balloon type)
- Sterile trocars for single use (Optical basic type)
- Sterile trocars for single use (Optical basic type) Dual pack
- Sterile trocars for single use (Universal cannula basic type)
Showing 12 of 280 declared devices.
Catalogue references include GA-SI0533-DS, GA-TAO1010, GN-T1010-C, GN-TBF0575, GN-TF0510-C, GN-TF1015-C.
European nomenclature codes declared: K01010101, K01010103, K01020117, K01020107, K01010105, K01010102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 280 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 280 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GENMED ENTERPRISES INTERNATIONAL LTD |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2026-01-09 |
Licence types: Device Family (4).
Licensed under: STERILE TROCARS FOR SINGLE USE, STERILE SPECIMEN RETRIEVAL BAGS FOR SINGLE USE, STERILE INSUFFLATION NEEDLES FOR SINGLE USE, STERILE SUCTION IRRIGATIONS FOR SINGLE USE.
North American profile: Canada only. GENMED ENTERPRISES INTERNATIONAL LTD holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
DZ 2318749-1 | supplemented | 2027-01-20 |