RoweMed AG - Medical 4 Life
DE-MF-000005350 · Germany · Parchim
RoweMed AG - Medical 4 Life is registered in the European database on medical devices as a manufacturer, with 130 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 130 |
|---|
Among these devices, 130 are declared sterile.
Devices declared under this manufacturer
- Alpha Paed Set I
- RoweBagSpike Chemo SV; Ø 3,0x4,1 mm; 30 cm; PVC; Schlauchklemme; Spike
- RoweEpiflow
- RoweEpiflow (PC) Neuraxial; 0,2 µm PET-Membran
- RoweEpiflow Neuraxial; 0,2 µm PET-Membran
- RoweFil 120 V; 0,2 µm pos. gel. Nylon-Membran; Ø 1,5x2,7 mm; PUR; RSV;
- RoweFil; 0,2 µm PET-Membran; Ø 1,5x2,7 mm; 10 cm; PUR; LLw/LLm
- RoweSpike I Chemo SV eco
- RoweSpike II 5 µm SV
- RoweSpike II Chemo SV
- RoweSpike II Micro 5 µm
- RoweSpike II Micro Chemo
Showing 12 of 130 declared devices.
Catalogue references include A-2357/81, A-2374, A-2506, A-6415, A-6435/87, A-6436.
European nomenclature codes declared: A0704, A04010101, C010180, B0180, C01040199, A04010102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | RoweMed AG - Medical 4 Life (DE) · FDA 3007751444 |
| Devices in EUDAMED | 130 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 130 |
|---|---|
| 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: United States only. RoweMed AG - Medical 4 Life is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2026GB448250304 | supplemented | 2028-02-02 |