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 Prices MDCGPDF |
| IVDR | SGS Belgium NV - Public PricesPDF |
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 | 158 | 60.8% | |
| Supplemented | 58 | 22.3% | |
| Amended | 36 | 13.8% | |
| Restricted | 7 | 2.7% | |
| Cancelled | 1 | 0.4% | |
| Total recorded | 260 | 100% |
+ 2 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 | 76 | |
| Class IIa | 157 | ||
| Class IIb | 68 | ||
| Class III | 11 | ||
| IVDR | IVDR Class C | 1 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, SGS Belgium NV (NB 1639) has issued 260 certificates: 259 under the EU MDR and 1 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
SGS Belgium NV (notified body 1639) is a Belgium notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 260 certificates (259 MDR, 1 IVDR) to 244 manufacturers across 25 countries.
Lens 05 · Who relies on it
What it means: 244 distinct manufacturers across 25 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 🇨🇳 CN | 4 |
| CLOUDS OF CARE NV | 🇧🇪 BE | 2 |
| Shenzhen Comen Medical Instruments Co.,LTD. | 🇨🇳 CN | 2 |
| APT Medical Inc. | 🇨🇳 CN | 2 |
| Ningbo Chinmed Technology Co.,Ltd | 🇨🇳 CN | 2 |
| Tianjin Plastics Research Institute Co., Ltd. | 🇨🇳 CN | 2 |
| S.E. Carburos Metálicos, S.A. | 🇪🇸 ES | 2 |
| RADIOLOGÍA, S.A. | 🇪🇸 ES | 2 |
| 🇬🇧 GB | 2 | |
| 🇬🇧 GB | 2 | |
| 🇬🇧 GB | 2 | |
| 🇭🇰 HK | 2 | |
| 🇭🇰 HK | 2 | |
| 🇰🇷 KR | 2 | |
| 🇧🇪 BE | 1 | |
| 🇧🇪 BE | 1 | |
| 🇧🇪 BE | 1 | |
| 🇧🇪 BE | 1 | |
| 🇧🇪 BE | 1 | |
| 🇧🇪 BE | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇨🇳 China | 76 | |
| 🇺🇸 United States | 22 | |
| 🇰🇷 South Korea | 18 | |
| 🇧🇪 Belgium | 16 | |
| 🇬🇧 United Kingdom | 15 | |
| 🇪🇸 Spain | 14 | |
| 🇫🇷 France | 13 |
Lens 01 · Mandate
The regulations this body is designated under, plus any predecessor directives.
| Regulation | Designation | Authoritative record |
|---|---|---|
| Active | Verify on NANDO | |
| 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.
| 🇯🇵 Japan | 13 |
| across 244 manufacturers | 244 | 25 countries total |