ROELMI HPC SRL
IT-MF-000026619 · Italy · ORIGGIO
ROELMI HPC SRL is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Devices declared under this manufacturer
- BACTIGYN OVULES
- GYNEXELLE ACTI-GYN
- ISDIN WOMAN OVULES VAGINAL DM - 2 OVULI
- ISDIN WOMAN OVULOS VAGINALES
- Infectim plus
- Intimique ovuli
Catalogue references include R.NT.PR.MDEV.0300, R.NT.PR.MDEV.0310.2, R.NT.PR.MDEV.0310.3, R.NT.PR.MDEV.0310.5, R.NT.PR.MDEV.0310.6, R.NT.PR.MDEV.0310.7.
European nomenclature codes declared: U0803.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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. ROELMI HPC SRL was not found in either the U.S. or the Canadian register.