EMED SP. Z O. O. SP. K.
PL-MF-000012648 · Poland · Opacz Kolonia
EMED SP. Z O. O. SP. K. is registered in the European database on medical devices as a manufacturer, with 349 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 248 |
|---|---|
| Class IIa | 101 |
Among these devices, 27 are declared sterile, 21 reusable, 250 active.
Devices declared under this manufacturer
- Argon needle 14mm, rigid, insulated shaft, 115mm w. length, dia. 5mm
- Ball electrode straight, 2mm, handle 4mm
- Bipolar cable for WOLF laparoscopy, L: 3m, 2-pin 29mm plug
- Bipolar forceps QuickTip, bayonet, non-stick, 1mm, L: 195mm
- Bipolar forceps, bayonet, angled, up, 1mm, L: 195mm
- Insert: micro-grasper, fenestrated, L: 340mm, reusable, for bipolar la
- Loop electrode, 20 x 20mm, L: 120mm, handle 2.4mm
- Monopolar cable for argon flexible electrode, L: 3.5m, SDS/LuerLock pl
- MultiSwitch, two-pedal footswitch, cable 5m, 6-pin plug
- Needle electrode, angled 45 °, handle 1,6mm
- Needle electrode, straight, 0.7mm, handle 4mm
- One-pedal footswitch, for CUTTING, wireless
Showing 12 of 349 declared devices.
Catalogue references include 100-314, 352-030, 521-020, 521-210, 521-410, 535-100.
European nomenclature codes declared: L180601, L181003, L180401, L180102, L180602, Z12010980.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 349 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 349 |
|---|---|
| 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. EMED SP. Z O. O. SP. K. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TNP/MDR/0034/4919/2025 | supplemented | 2028-05-05 |