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 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 | 3 | 100% | |
| Total recorded | 3 | 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 | 2 | |
| Class IIa | 1 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, CESKY METROLOGICKY INSTITUT (NB 1383) has issued 3 certificates: 3 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
CESKY METROLOGICKY INSTITUT (notified body 1383) is a Czechia notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 3 certificates (3 MDR, 0 IVDR) to 3 manufacturers across 1 countries.
Lens 05 · Who relies on it
What it means: 3 distinct manufacturers across 1 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| VDI Technologies s.r.o. | 🇨🇿 CZ | 1 |
| Drillbone s.r.o. | 🇨🇿 CZ | 1 |
| HTG medical s.r.o. | 🇨🇿 CZ | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇨🇿 Czechia | 3 | |
| across 3 manufacturers | 3 | 1 countries total |