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) | — |
| AIMDD(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Per-regulation status (active / suspended / withdrawn) is not published in the EUDAMED payload — we show Designated and link to NANDO rather than a status we cannot verify.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.
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 |
|---|---|---|---|
| Issued | 378 | 61.5% | |
| Supplemented | 129 | 21% | |
| Amended | 41 | 6.7% | |
| Reissued | 40 | 6.5% | |
| Cancelled | 19 | 3.1% | |
| Withdrawn | 3 | 0.5% | |
| Restricted | 3 | 0.5% | |
| Suspended | 2 | 0.3% | |
| Total recorded | 615 | 100% |
+ 49 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 | 215 | |
| Class IIa | 335 | ||
| Class IIb | 160 | ||
| Class III | 22 | ||
| IVDR | IVDR Class A | 8 | |
| IVDR Class B | 42 | ||
| IVDR Class C | 56 | ||
| IVDR Class D | 29 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, TÜV Rheinland LGA Products GmbH (NB 0197) has issued 615 certificates: 515 under the EU MDR and 100 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
TÜV Rheinland LGA Products GmbH (notified body 0197) is a Germany notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 615 certificates (515 MDR, 100 IVDR) to 513 manufacturers across 31 countries.
Lens 05 · Who relies on it
What it means: 513 distinct manufacturers across 31 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| 🇩🇪 DE | 21 | |
| 🇩🇪 DE | 5 | |
| 🇨🇳 CN | 3 | |
| 🇨🇳 CN | 3 | |
| 🇩🇪 DE | 3 | |
| 🇩🇪 DE | 3 | |
| 🇭🇺 HU | 3 | |
| 🇯🇵 JP | 3 |
| FUJIFILM Corporation | 🇯🇵 JP | 3 |
| Terumo Corporation | 🇯🇵 JP | 3 |
| GenBody Inc. | 🇰🇷 KR | 3 |
| Stryker Instruments | 🇺🇸 US | 3 |
| PROMEDON S.A. | 🇦🇷 AR | 2 |
| Hamilton Medical AG | 🇨🇭 CH | 2 |
| Lepu Medical Technology (Beijing) Co., Ltd. | 🇨🇳 CN | 2 |
| GE Healthcare Tianjin Company Limited | 🇨🇳 CN | 2 |
| GE Medical Systems CO. Ltd | 🇨🇳 CN | 2 |
| Assure Tech. (Hangzhou) Co., Ltd. | 🇨🇳 CN | 2 |
| Taian Dalu Medical Instrument Co., Ltd. | 🇨🇳 CN | 2 |
| Hangzhou Yiguoren Biotechnology Co.,Ltd. | 🇨🇳 CN | 2 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇨🇳 China | 282 | |
| 🇩🇪 Germany | 73 | |
| 🇺🇸 United States | 26 | |
| 🇯🇵 Japan | 23 | |
| 🇵🇱 Poland | 19 | |
| 🇰🇷 South Korea | 16 | |
| 🇨🇭 Switzerland | 8 | |
| 🇬🇧 United Kingdom | 8 | |
| across 513 manufacturers | 513 | 31 countries total |