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 06 · Published fees
What it means: notified bodies must make their standard fees publicly available (Article 50 MDR, Article 46 IVDR). The European Commission keeps an index of the fee lists it has been given.
| Regulation | Fee list |
|---|---|
| MDR | Eurofins MDR FeesPDF |
Links come from the European Commission's index of notified-body fee lists. We link out to each body's own site — we do not host the documents, read the amounts, or check that a link still resolves. Index retrieved Jul 14, 2026. Open the source index →
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 | 54 | 60% | |
| Reissued | 36 | 40% | |
| Total recorded | 90 | 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 I | 4 | |
| Class IIa | 19 | ||
| Class IIb | 40 | ||
| 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 90 certificates: 90 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 90 certificates (90 MDR, 0 IVDR) to 31 manufacturers across 6 countries.
Lens 05 · Who relies on it
What it means: 31 distinct manufacturers across 6 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| IBSA FARMACEUTICI ITALIA SRL | 🇮🇹 IT | 9 |
| ABOCA S.P.A. SOCIETÀ AGRICOLA | 🇮🇹 IT | 9 |
| FARMA-DERMA S.r.l. | 🇮🇹 IT | 8 |
| Drugs Minerals and Generics Italia S.r.l. | 🇮🇹 IT | 8 |
| LO.LI. PHARMA S.r.l. | 🇮🇹 IT | 5 |
| Innate s.r.l. | 🇮🇹 IT | 5 |
| Laboratoires Fill-Med | 🇫🇷 FR | 4 |
| AUDIO TECHNOLOGIES SRL | 🇮🇹 IT | 4 |
| 🇮🇹 IT | 4 | |
| 🇦🇹 AT | 3 | |
| 🇮🇹 IT | 3 | |
| 🇳🇱 NL | 3 | |
| 🇨🇳 CN | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇸🇪 SE | 2 | |
| 🇨🇳 CN | 1 | |
| 🇨🇳 CN | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇮🇹 Italy | 22 | |
| 🇨🇳 China | 3 | |
| 🇫🇷 France | 3 | |
| 🇦🇹 Austria | 1 | |
| 🇳🇱 Netherlands | 1 | |
| 🇸🇪 Sweden | 1 | |
| across 31 manufacturers | 31 | 6 countries total |
Lens 01 · Mandate
The regulations this body is designated under, plus any predecessor directives.
| Regulation | Designation | Authoritative record |
|---|---|---|
| MDR — Read the full text | Active | Verify on NANDO |
| MDD(legacy) | Designated (legacy) | — |
“Active” means the designation is currently valid in NANDO, the EU’s official register; where NANDO does not confirm an active status we show “Designated” and link out rather than a status we cannot verify. Active status verified on NANDO Aug 17, 2026. Official scope of designation is published on NANDO →