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 | SGS Fimko List of Standard Fees 2024PDF |
| IVDR | SGS FIMKO OY Standard 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 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 | 40.8% | |
| Supplemented | 25 | 32.9% | |
| Reissued | 10 | 13.2% | |
| Amended | 8 | 10.5% | |
| Withdrawn | 1 | 1.3% | |
| Cancelled | 1 | 1.3% | |
| Total recorded | 76 | 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 | 63 | ||
| 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 76 certificates: 76 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 — Read the full text | Active | Verify on NANDO |
| MDR — Read the full text | 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 Aug 24, 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 76 certificates (76 MDR, 0 IVDR) to 62 manufacturers across 6 countries.
Lens 05 · Who relies on it
What it means: 62 distinct manufacturers across 6 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| 🇨🇳 CN | 2 | |
| 🇨🇳 CN | 2 | |
| 🇩🇪 DE | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 | |
| 🇫🇮 FI | 2 |
| Kustannus Oy Duodecim | 🇫🇮 FI | 2 |
| Planmeca Oy | 🇫🇮 FI | 2 |
| Planmed Oy | 🇫🇮 FI | 2 |
| Optomed Oyj | 🇫🇮 FI | 2 |
| Combinostics Oy | 🇫🇮 FI | 2 |
| Cerenion Oy | 🇫🇮 FI | 2 |
| General Medical Italia LTD Swiss Branch | 🇨🇭 CH | 1 |
| Shenzhen Comen Medical Instruments Co.,LTD. | 🇨🇳 CN | 1 |
| Wuhan Zoncare Bio-medical Electronics Co.,Ltd | 🇨🇳 CN | 1 |
| CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD | 🇨🇳 CN | 1 |
| FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD | 🇨🇳 CN | 1 |
| Northern Meditec Limited | 🇨🇳 CN | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇫🇮 Finland | 28 | |
| 🇨🇳 China | 25 | |
| 🇩🇪 Germany | 6 | |
| 🇨🇭 Switzerland | 1 | |
| 🇸🇪 Sweden | 1 | |
| 🇺🇸 United States | 1 | |
| across 62 manufacturers | 62 | 6 countries total |