TEDISEL IBERICA S.L.
ES-MF-000026074 · Spain · Badalona
TEDISEL IBERICA S.L. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 23 |
|---|---|
| Class IIb | 9 |
Most frequent device types declared: BASIC-MS, BASIC-SC, DIAMOND, INFUSION STAND, SICA.
Among these devices, 9 are declared active.
Devices declared under this manufacturer
- B-ADONIS
- B-AIS
- B-AURA
- B-N270
- B-SCOLUMN
- B-TOR
- COLUMN
- DIAMOND L+
- DIAMOND M
- DIAMOND M+
- DIAMOND M++
- DIAMOND XL
Showing 12 of 32 declared devices.
Catalogue references include B-AURA, B-N270, B-SCOLUMN, B-TOR, DIAMOND L+, DIAMOND M+.
European nomenclature codes declared: Z129007, Z129017, Z11900802, Z12030380, V08068001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 32 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| 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. TEDISEL IBERICA S.L. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1000382-1 | issued | 2031-06-18 |