SC SPD STAR SRL
RO-MF-000004404 · Romania · CASEIU
SC SPD STAR SRL is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 20 |
|---|
Among these devices, 19 are declared sterile.
Devices declared under this manufacturer
- COMPRESE STERILE PLIATE 10 CM X 20 CM X 8 PLIURI 5 BUCĂȚI
- COPROCULTOR LIVSANE 30 ML
- COPROCULTOR SANVERO 30 ML
- COPROCULTOR SPD STAR 30 ML
- SANEO
- TIFON PLIAT 10M X 90CM
- UROCULTOR LIVSANE 60 ML
- UROCULTOR ONEDIA 120 ML
- UROCULTOR ONEDIA 60 ML
- VATA HIDROFILA DE UZ MEDICINAL 100 GR
- VATA HIDROFILA DE UZ MEDICINAL 200 GR
- Vata Hidrofila Narcis 80gr
Showing 12 of 34 declared devices.
Catalogue references include CD0630, CO0320, CTDS16, UO0460, VCF100, VN100.
European nomenclature codes declared: M010101, W05010203, W05019001, M0201020102, M0201020101, M0201010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 34 |
| 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 | 34 |
|---|---|
| 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. SC SPD STAR SRL was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR.2292-2025/0006 | issued | 2030-04-14 |