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 01 · Mandate
The regulations this body is designated under, plus any predecessor directives.
| Regulation | Designation | Authoritative record |
|---|---|---|
| MDR | Designated | Verify on NANDO ↗ |
| MDD(legacy) | Designated (legacy) | — |
Per-regulation status (active / suspended / withdrawn) is not published in the EUDAMED payload — we show Designated and link to NANDO rather than a status we cannot verify. Official scope of designation is published on NANDO →
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| Withdrawn | 1 | 3.4% | |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 ↗.
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 |
|---|---|---|
| CMD GmbH | 🇦🇹 AT | 1 |
| Idevax BV | 🇧🇪 BE | 1 |
| BE-PR-000044136 | 🇧🇪 BE | 1 |
| Cisabrasile Ltda. | 🇧🇷 BR | 1 |
| veldana medical S.A. | 🇨🇭 CH | 1 |
| Pall International SARL | 🇨🇭 CH | 1 |
| CN-PR-000013744 | 🇨🇳 CN | 1 |
| Ursatec GmbH | 🇩🇪 DE | 1 |
| 🇪🇸 ES | 1 | |
| 🇫🇷 FR | 1 | |
| 🇫🇷 FR | 1 | |
| 🇫🇷 FR | 1 | |
| 🇫🇷 FR | 1 | |
| 🇫🇷 FR | 1 | |
| 🇬🇧 GB | 1 | |
| 🇬🇧 GB | 1 | |
| 🇬🇧 GB | 1 | |
| 🇮🇱 IL | 1 | |
| 🇮🇱 IL | 1 | |
| 🇮🇹 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 |