Home › Italy › SIGMA ENGINEERING S.r.l.
Manufacturer of medical devices registered in the European database in Fonte Nuova (RM), Italy.
| Registration number (SRN) | IT-MF-000029426 |
|---|---|
| Role | Manufacturer |
| Status | Inactive |
| Country | Italy |
| City | 00010 Fonte Nuova (RM) |
| Address | Valle dei Corsi, 10 00010 Fonte Nuova (RM) |
| Registered on | 2022-10-10 |
| FDA establishment register | Not found in the U.S. FDA register |
|---|
⚠️ Not found is not the same as not registered. The two registers share no common identifier; the comparison is made on company names. This manufacturer may reach the United States through a distributor, or be registered under a name we could not match. State of the FDA register on 2026-08-20.
| Certificate | Status | Expiry | Type | Body |
|---|---|---|---|---|
IT328666 | valid | 2029-01-11 | Quality management system | NB 1370 |
⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.
This operator is listed as inactive. The register does not publish the reason — cessation, change of legal form, or withdrawal from the European market. We do not guess it.
The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.
An inactive registration is not, by itself, a verdict — it may be a cessation, a change of legal form, or a withdrawal from the Union market, and the register does not say which. What we can tell you is when a supplier's status changes: the register does not date those changes, so only comparing two snapshots reveals them. That is what the monitoring does.
We reply from a person, not a sequence. One message, and none after that if you do not answer.