DELTAROM SRL
RO-MF-000035924 · Romania · Giurgiu
DELTAROM SRL is registered in the European database on medical devices as a manufacturer, with 866 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- AGAR BAZAPSEUDOMONAS
- AGAR COLUMBIA CNA (SANGE BERBEC 5%)
- AGAR LEGIONELLA
- AGARA NITRAT
- BULION F.B. FASTIDIOUS
- BULION MYCOSEL
- BULION NITRAT
- COLUMBIA CNA MOD. AGAR (SANGE BERBEC 5%)
- LOWENSTEIN JENSEN + ISONIAZID 0.20 µg/mL
- LOWENSTEIN JENSEN + PYRAZINAMIDE 1 µg/mL
- MEDIU MILF (MEDIU MOTILITATE INDOL LISINA FENILALANINA
- MIDDLEBROOK 7H11 + AMIKACIN 4 µg/mL
Showing 12 of 866 declared devices.
Catalogue references include 340285, 340531, 341571, 341805, 342035, 342361.
European nomenclature codes declared: W0104010306, W0104010101, W0104010206, W0104010405, W0104010804, W0104010402.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 866 |
| Country of registration | Romania |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 866 |
|---|---|
| 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. DELTAROM SRL was not found in either the U.S. or the Canadian register.