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.
Modern MDR device-group codes (MDA / MDN / MDS / MDT) are not yet populated on this body's certificates — consistent with the EUDAMED data ramp.
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 | 10 | 83.3% | |
| Reissued | 2 | 16.7% | |
| Total recorded | 12 | 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 | 4 | |
| Class IIa | 6 | ||
| Class IIb | 3 | ||
| Class III | 11 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, BSI Group The Netherlands B.V. (NB 2797) has issued 12 certificates: 12 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
BSI Group The Netherlands B.V. (notified body 2797) is a Netherlands notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 12 certificates (12 MDR, 0 IVDR) to 9 manufacturers across 3 countries.
Lens 05 · Who relies on it
What it means: 9 distinct manufacturers across 3 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| CooperSurgical, Inc. | 🇺🇸 US | 3 |
| Tandem Diabetes Care, Inc. | 🇺🇸 US | 2 |
| Henan Tuoren Best Medical Device Co., Ltd. | 🇨🇳 CN | 1 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 🇨🇳 CN | 1 |
| Guangdong Baihe Medical Technology Co., Ltd | 🇨🇳 CN | 1 |
| Medica Europe B.V. | 🇳🇱 NL | 1 |
| Biomet Microfixation | 🇺🇸 US | 1 |
| LSI SOLUTIONS, Inc. | 🇺🇸 US | 1 |
| 🇺🇸 US | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇺🇸 United States | 5 | |
| 🇨🇳 China | 3 | |
| 🇳🇱 Netherlands | 1 | |
| across 9 manufacturers | 9 | 3 countries total |
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 ↗ |
| IVDD(legacy) | Designated (legacy) | — |
| AIMDD(legacy) | Designated (legacy) |
| 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. Active status verified on NANDO Jun 29, 2026. Official scope of designation is published on NANDO →