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EUDAMED last updated this device on Jun 10, 2026
++EBRM2aInstMounterNHPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →SKYMLVD475 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by bredent medical GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →+EBRMSKYMLVD4750%Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →++EBRM2aInstMounterNHSKYMLVD475UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →+EBRMSKYMLVD4750%
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
L159099ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHERSterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 31 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Nov 27, 2025 | Still on market |
| Austria | Nov 27, 2025 | Still on market |
| Belgium | Nov 27, 2025 | Still on market |
| Bulgaria | Nov 27, 2025 | Still on market |
| Cyprus | Nov 27, 2025 | Still on market |
| Czechia | Nov 27, 2025 | Still on market |
| Denmark | Nov 27, 2025 | Still on market |
| Estonia | Nov 27, 2025 | Still on market |
| EL | Nov 27, 2025 | Still on market |
| Spain | Nov 27, 2025 | Still on market |
| Finland | Nov 27, 2025 | Still on market |
| France | Nov 27, 2025 | Still on market |
| Croatia | Nov 27, 2025 | Still on market |
| Hungary | Nov 27, 2025 | Still on market |
| Ireland | Nov 27, 2025 | Still on market |
| Iceland | Nov 27, 2025 | Still on market |
| Italy | Nov 27, 2025 | Still on market |
| Liechtenstein | Nov 27, 2025 | Still on market |
| Lithuania | Nov 27, 2025 | Still on market |
| Luxembourg | Nov 27, 2025 | Still on market |
| Latvia | Nov 27, 2025 | Still on market |
| Malta | Nov 27, 2025 | Still on market |
| Netherlands | Nov 27, 2025 | Still on market |
| Norway | Nov 27, 2025 | Still on market |
| Poland | Nov 27, 2025 | Still on market |
| Portugal | Nov 27, 2025 | Still on market |
| Romania | Nov 27, 2025 | Still on market |
| Sweden | Nov 27, 2025 | Still on market |
| Slovenia | Nov 27, 2025 | Still on market |
| Slovakia | Nov 27, 2025 | Still on market |
| XI | Nov 27, 2025 | Still on market |
DE-MF-000008125No 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.