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 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 |
|---|---|---|---|
| Issued | 31 | 41.9% | |
| Supplemented | 24 | 32.4% | |
| Reissued | 10 | 13.5% | |
| Amended | 7 | 9.5% | |
| Withdrawn | 1 | 1.4% | |
| Cancelled | 1 | 1.4% | |
| Total recorded | 74 | 100% |
+ 8 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 | 61 | ||
| Class IIb | 17 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, SGS FIMKO OY (NB 0598) has issued 74 certificates: 74 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 |
|---|---|---|
| IVDR | Active | Verify on NANDO ↗ |
| MDR | Active | Verify on NANDO ↗ |
“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 Jul 6, 2026. Official scope of designation is published on NANDO →
In one line
SGS FIMKO OY (notified body 0598) is a Finland notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 74 certificates (74 MDR, 0 IVDR) to 60 manufacturers across 6 countries.
Lens 05 · Who relies on it
What it means: 60 distinct manufacturers across 6 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | 🇨🇳 CN | 2 |
| AOJ HEALTH Technology Co., Ltd. | 🇨🇳 CN | 2 |
| Gründler GmbH | 🇩🇪 DE | 2 |
| Icare Finland Oy | 🇫🇮 FI | 2 |
| BCB Medical Oy | 🇫🇮 FI | 2 |
| DigiFinland Oy | 🇫🇮 FI | 2 |
| Serres Oy | 🇫🇮 FI | 2 |
| Sooma Oy | 🇫🇮 FI | 2 |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇨🇭 CH | 1 | |
| 🇨🇳 CN | 1 | |
| 🇨🇳 CN | 1 | |
| 🇨🇳 CN | 1 | |
| 🇨🇳 CN | 1 | |
| 🇨🇳 CN | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇫🇮 Finland | 28 | |
| 🇨🇳 China | 23 | |
| 🇩🇪 Germany | 6 | |
| 🇨🇭 Switzerland | 1 | |
| 🇸🇪 Sweden | 1 | |
| 🇺🇸 United States | 1 | |
| across 60 manufacturers | 60 | 6 countries total |