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 | ECM 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 | 18 | 62.1% | |
| Supplemented | 10 | 34.5% | |
| Withdrawn | 1 | 3.4% | |
| Total recorded | 29 | 100% |
+ 1 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 | 6 | |
| Class IIa | 15 | ||
| Class IIb | 10 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, ENTE CERTIFICAZIONE MACCHINE SRL (NB 1282) has issued 29 certificates: 29 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 ↗.
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 →
In one line
ENTE CERTIFICAZIONE MACCHINE SRL (notified body 1282) is a Italy notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 29 certificates (29 MDR, 0 IVDR) to 29 manufacturers across 17 countries.
Lens 05 · Who relies on it
What it means: 29 distinct manufacturers across 17 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| 🇦🇹 AT | 1 | |
| 🇧🇪 BE | 1 | |
| 🇧🇪 BE | 1 | |
| 🇧🇷 BR | 1 | |
| 🇨🇭 CH | 1 | |
| 🇨🇭 CH | 1 | |
| 🇨🇳 CN | 1 | |
| 🇩🇪 DE | 1 |
| Tucuvi Care, S.L | 🇪🇸 ES | 1 |
| Didactic | 🇫🇷 FR | 1 |
| France Développement Electronique | 🇫🇷 FR | 1 |
| V.I.M.S VIDEO INTERVENTIONNELLE MEDICALE SCIENTIFIQUE | 🇫🇷 FR | 1 |
| Withings | 🇫🇷 FR | 1 |
| MESURONS | 🇫🇷 FR | 1 |
| East Midlands Pharma Limited | 🇬🇧 GB | 1 |
| Alliance Pharmaceuticals Limited | 🇬🇧 GB | 1 |
| Signifier Medical Technologies Limited | 🇬🇧 GB | 1 |
| Medoc Ltd | 🇮🇱 IL | 1 |
| First Care Products Ltd. | 🇮🇱 IL | 1 |
| WiQo S.p.A. | 🇮🇹 IT | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇫🇷 France | 5 | |
| 🇬🇧 United Kingdom | 3 | |
| 🇺🇰 United Kingdom | 3 | |
| 🇧🇪 Belgium | 2 | |
| 🇨🇭 Switzerland | 2 | |
| 🇮🇱 Israel | 2 | |
| 🇱🇹 Lithuania | 2 | |
| 🇦🇹 Austria | 1 | |
| across 29 manufacturers | 29 | 17 countries total |