PANEP s.r.o.
CZ-MF-000033142 · Czechia · Rosice
PANEP s.r.o. is registered in the European database on medical devices as a manufacturer, with 202 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 202 |
|---|
Among these devices, 173 are declared sterile.
Devices declared under this manufacturer
- Drill cover 7x170cm, with introduction card and fixation tape, sterile
- Equipment cover 70x80cm, flat, sterile
- Equipment cover 80x85cm, flat, sterile
- Equipment cover 85x90cm, flat, sticker, sterile
- Extremity drape 245x310cm, Fen.9x80cm, LEFT
- Gauze balls 20x20cm, 1x40pcs, sterile
- Gauze balls 30x30cm, 1x2pcs, 2ply, sterile
- Gauze balls 9x9cm, 1x5pcs, sterile
- Gauze sponges 20x30cm, 16ply (CE)
- Gauze sponges 7x250cm, 1pc, sterile
- Gauze sponges 8x17cm, 1x50pcs, 12ply, sterile
- Gauze sponges with cellulose wadding 7x10cm, 1x5pcs, sterile
Showing 12 of 202 declared devices.
Catalogue references include 26503, 28024, 28031, 28039, 37022, 37503.
European nomenclature codes declared: T020102, Z1399, M0201020101, M020199, M0201020102, M0202010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 202 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 202 |
|---|---|
| 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. PANEP s.r.o. was not found in either the U.S. or the Canadian register.