MARGOMED SPÓŁKA AKCYJNA
PL-MF-000009261 · Poland · Lublin
MARGOMED SPÓŁKA AKCYJNA is registered in the European database on medical devices as a manufacturer, with 215 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 210 |
|---|
Most frequent device types declared: ASCOSET; UNI-ASCOSET, Extension tubing for infusion pump, UV protected extension tubing for , Infusion extension tubing, UV protected infusion extension tubing, Infusion set type: IS; with injection site; PREMIUM; PRO; AIR PASS; SA, LuxInject syringe, ProInject syringe.
Among these devices, 207 are declared sterile, 37 with a measuring function.
Devices declared under this manufacturer
- ASCOSET Peristaltic do pompy perystaltycznej-AP31P
- Extension tubing for infusion pump
- Infusion extension tubing
- Infusion set IS PREMIUM
- Infusion set IS PREMIUM with injection site
- Infusion set IS PRO AIR PASS
- Infusion set IS PRO SAFETY with needle-free injection site
- Sterile urine container
- Transfusion set TS
- UV protected ProPrecision syringe for infusion pump
- UV protected extension tubing for infusion pump
- UV protected infusion extension tubing
Showing 12 of 215 declared devices.
Catalogue references include 001 757, 001 760, 001 903P, 001 911P, 004 253, 004 811.
European nomenclature codes declared: A03020199, A03040199, A020199, Z121799, V0380, A02010203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 215 |
| 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 | 215 |
|---|---|
| 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. MARGOMED SPÓŁKA AKCYJNA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 2631342-1 | issued | 2030-04-24 |