Notified body · Verified from EUDAMED
We show only what EUDAMED publishes. EUDAMED is still being populated — the absence of a certificate here does not mean none exists. Every figure links back to the official record so you can verify it yourself.
Lens 03 · Certificates
What it means: most of this body's certificates are live; a small share have ended or had adverse action.
| Status | Count | Distribution | Share |
|---|---|---|---|
| Issued | 31 | 63.3% | |
| Reissued | 18 | 36.7% | |
| Total recorded | 49 | 100% |
+ 0 expired (derived from the expiry date, not a EUDAMED status).
New certificates per year — the curve of EUDAMED adoption.
Lens 04 · What it certifies
What it means: higher classes (MDR III, IVDR D) carry the strictest scrutiny — a window into how high-stakes this body's work runs.
| Framework | Class | Certs | Distribution |
|---|---|---|---|
| MDR | Class IIa | 3 | |
| Class IIb | 17 | ||
| Class III | 29 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, Eurofins Product Testing Italy S.r.l. (NB 0477) has issued 49 certificates: 49 under the EU MDR and 0 under the EU IVDR. EUDAMED is still being populated, so this is a lower bound, not a complete history.
Across its issued certificates it has covered MDR Class I, IIa, IIb and III devices and IVDR Class A, B, C and D devices, including the highest-risk MDR Class III and IVDR Class D.
Yes. This body is designated under the EU IVDR (2017/746) and the EU MDR (2017/745), plus the legacy AIMDD, MDD and IVDD directives. Its official scope of designation is published on NANDO ↗.
In one line
Eurofins Product Testing Italy S.r.l. (notified body 0477) is a Italy notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 49 certificates (49 MDR, 0 IVDR) to 19 manufacturers across 5 countries.
Lens 05 · Who relies on it
What it means: 19 distinct manufacturers across 5 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| IBSA FARMACEUTICI ITALIA SRL | 🇮🇹 IT | 9 |
| Innate s.r.l. | 🇮🇹 IT | 5 |
| Laboratoires Fill-Med | 🇫🇷 FR | 4 |
| AUDIO TECHNOLOGIES SRL | 🇮🇹 IT | 4 |
| Mastelli S.r.l. | 🇮🇹 IT | 4 |
| SICO Società Italiana Carburo Ossigeno S.p.A. | 🇮🇹 IT | 3 |
| Medical Brands Developments BV | 🇳🇱 NL | 3 |
| MOSS S.p.A. | 🇮🇹 IT | 2 |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇸🇪 SE | 2 | |
| 🇨🇳 CN | 1 | |
| 🇫🇷 FR | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇮🇹 Italy | 14 | |
| 🇫🇷 France | 2 | |
| 🇨🇳 China | 1 | |
| 🇳🇱 Netherlands | 1 | |
| 🇸🇪 Sweden | 1 | |
| across 19 manufacturers | 19 | 5 countries total |