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 |
|---|---|---|
| IVDR | Designated | Verify on NANDO ↗ |
| MDR | Designated | Verify on NANDO ↗ |
| IVDD(legacy) | Designated (legacy) | — |
| 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Per-regulation status (active / suspended / withdrawn) is not published in the EUDAMED payload — we show Designated and link to NANDO rather than a status we cannot verify.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 02 · From the certificates
Device-group families derived from the scope text of this body's issued certificates (often legacy nomenclature) — not the official NANDO designation scope.
Read from the certificate scope text, which is messy free-text and skews to legacy nomenclature. We render only the code families actually present rather than imply a modern device-group breakdown that isn't recorded.
These families are read from the issued certificates' scope text (often legacy nomenclature), not the official NANDO scope of designation.
MDA — Active devices
MDN — Non-active devices
MDS — Devices with specific characteristics (horizontal)
MDT — Devices using specific technologies / processes (horizontal)
IVR — IVD devices, base group (design / intended purpose)
IVS — IVDs with specific characteristics
IVT — IVDs using specific technologies
IVP — Specific examination-procedure knowledge
IVD — Specific laboratory / clinical-discipline knowledge
Source: Commission Implementing Reg (EU) 2017/2185; MDCG 2019-14 (MDR) / 2021-14 (IVDR).
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 |
|---|---|---|---|
| Supplemented | 20 | 64.5% | |
| Issued | 9 | 29% | |
| Amended | 2 | 6.5% | |
| Total recorded | 31 | 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 | 1 | |
| Class IIa | 19 | ||
| Class IIb | 10 | ||
| IVDR | IVDR Class B | 1 | |
| IVDR Class C | 4 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, Eurofins Electric & Electronics Finland Oy (NB 0537) has issued 31 certificates: 26 under the EU MDR and 5 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 Electric & Electronics Finland Oy (notified body 0537) is a Finland notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 31 certificates (26 MDR, 5 IVDR) to 30 manufacturers across 7 countries.
Lens 05 · Who relies on it
What it means: 30 distinct manufacturers across 7 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| Zhejiang Orient Gene Biotech Co., Ltd | 🇨🇳 CN | 2 |
| Vitacare GmbH & Co. KG | 🇩🇪 DE | 1 |
| CINOGY GmbH | 🇩🇪 DE | 1 |
| Galena Pharma Oy | 🇫🇮 FI | 1 |
| GE Healthcare Finland Oy | 🇫🇮 FI | 1 |
| Pharmia Oy | 🇫🇮 FI | 1 |
| Orion Oyj | 🇫🇮 FI | 1 |
| KiiltoClean Oy | 🇫🇮 FI | 1 |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 | |
| 🇫🇮 FI | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇫🇮 Finland | 22 | |
| 🇩🇪 Germany | 2 | |
| 🇸🇪 Sweden | 2 | |
| 🇨🇳 China | 1 | |
| 🇬🇧 United Kingdom | 1 | |
| 🇰🇷 South Korea | 1 | |
| 🇺🇸 United States | 1 |
| across 30 manufacturers | 30 | 7 countries total |