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EUDAMED last updated this device on Jul 22, 2025
425137579000A3ART 602K SAM® SE Artikulator kit AX, with screw type mounting plates is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by SAM Präzisionstechnik GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
DE-MF-000046397No certificate specifically references this device's Basic UDI-DI.
(01)04251375790010
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04251375790010Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
425137579000A3AXP 602KUDI 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.
Q0199ODONTOLOGY DEVICES - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No 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.4251375760009EOn the marketART 567PER SAM® 3 articulator professional kit, Peru for MPS-system425137579000A3On the marketART 601K SAM® SE Articulator Kit NT425137579000A3On the marketART 616MK SAM® SE articulator kit NT, MPS425137579000A3On the marketART 617MK SAM® SE artikulator kit AX425137579000A3On the marketART 651MK NEO articulator kit NT, MPS425137579000A3On the market