- Role
- Country
- Date of registration
- Address
PL-MF-000052302Root elevator BERNARD, slightly curved is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 29, 2026
B-05904151421026Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05904151421026
1 warning recorded — scroll inside the panel to see all entries.
Products made of stainless steel contain metals (in the form of alloying additives or in trace amounts) that may cause allergies (Nickel, Chromium, Cobalt). The product is contraindicated for people with allergies to any component of steel.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Poland; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05904151421026Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-05904151421026ST 5821UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
L159002DENTAL EXCAVATORS, REUSABLEB-05904151420524On the marketRoot elevator BERNARD, LUKSATOR handle, curved, right, 4 mmB-05904151420517On the marketRoot elevator BERNARD, LUKSATOR handle, straight, 4 mmB-05904151420548On the marketRoot elevator FLOHR, for lateral roots, BEIN handle, 130 mm, left, 3 mm, Fig. 2, angledB-05904151420333On the marketRoot elevator FLOHR, for lateral roots, BEIN handle, 130 mm, right, 3 mm, Fig. 2, angledB-05904151420340On the marketRoot elevator HEIDBRINK, LUXATOR handle, 155 mm, Fig. 2, curved, left, 2 mmB-05904151421064On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.No certificate specifically references this device's Basic UDI-DI.