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EUDAMED last updated this device on Jul 17, 2025
4251375760009EAXP 105S Axiojig Initial Set - each 20 Stk. 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.
04251375760518AXP 105S DE-MF-000046397(01)04251375760518
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.
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 →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 →UDI 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 →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 →No certificate specifically references this device's Basic UDI-DI.
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 marketAXP 103S Axiojig Bitefork FLJ, flat, with extended lower jaw bite platform4251375760009EOn the marketAXP 103XS Axiojig transfer fork - FLJ, ideal for class III, as deprogrammer & CR4251375760009EOn the marketAXP 105T Axiojig test set - 5 pc. (standard, FLJ, KS)4251375760009EOn the marketAXP 110S STARTER SET AG - for Aman Girrbach Rotofix4251375760009EOn the marketAXP 120 S Axioprisa Starter Set KV - KaVo Arcus, incl. 5 jigs each4251375760009EOn the market