GRUPO TRISTAN GLOBAL I&A, S.L.
ES-MF-000050246 · Spain · RIVAS-VACIAMADRID
GRUPO TRISTAN GLOBAL I&A, S.L. is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: IAMED-1101, IAMED-1108, IAMED-1202.
Devices declared under this manufacturer
- I&A MEDICAL Guantes de examen de LATEX sin polvo – Talla L – 100 unida
- I&A MEDICAL Guantes de examen de LATEX sin polvo – Talla M – 100 unida
- I&A MEDICAL Guantes de examen de LATEX sin polvo – Talla XL– 100 unida
- I&A MEDICAL Guantes de examen de látex sin polvo talla S
- I&A MEDICAL Guantes de examen de látex sin polvo talla XS
- I&A MEDICAL Guantes de examen de nitrilo sin polvo – Talla L – 100 uni
- I&A MEDICAL Guantes de examen de nitrilo sin polvo – Talla M – 100 uni
- I&A MEDICAL Guantes de examen de nitrilo sin polvo – Talla S – 100 uni
- I&A MEDICAL Guantes de examen de nitrilo sin polvo – Talla XL – 100 un
- I&A MEDICAL Guantes de examen de nitrilo sin polvo – Talla XS – 100 un
- I&A MEDICAL Guantes de examen de vinilo sin polvo talla L
- I&A MEDICAL Guantes de examen de vinilo sin polvo talla M
Showing 12 of 14 declared devices.
Catalogue references include IAMED-1101, IAMED-1102, IAMED-1108, IAMED-1202.
European nomenclature codes declared: T01020204, T010201, T01020201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| 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 | 14 |
|---|---|
| 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. GRUPO TRISTAN GLOBAL I&A, S.L. was not found in either the U.S. or the Canadian register.