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EUDAMED last updated this device on May 20, 2026
8055731430CFACCESSORY.SLUDADO M8 ALTO 12MM ST 20PZ is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Mikai s.p.a.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080566305525275000M54LST20IT-MF-000030732(01)08056630552527
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 warnings recorded — scroll inside the panel to see all entries.
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 Italy; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Croatia | — | Still on market |
| Ireland | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Slovakia | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
P0912040102AXIAL BONE FIXATION SYSTEMSPrimary 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 →Certificate health across this manufacturer's portfolio.
ITH 1343576 1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →8055731430CFACCESSORY.SLUOn the marketDADO M6 CON INSERTO IN NYLON ST 20PZ8055731430CFACCESSORY.SLUOn the marketDADO M8 12MM ST 20PZ8055731430CFACCESSORY.SLUOn the marketDADO M8 CON INSERTO IN NYLON ST 20PZ8055731430CFACCESSORY.SLUOn the marketDADO MINISTYLO PER ALLUNGAMENTO ST805573143STYACCESSORY.SEKOn the marketDISTANZIALE BASE L100MM ST8055731430CF0000STRUT.SVCOn the marketNo certificate specifically references this device's Basic UDI-DI.