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EUDAMED last updated this device on Mar 2, 2026
805809010347000G2SiSilicon Fix is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Pikdare S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08058090051367580103530000002 packaging levels registered — each level carries its own UDI-DI.
08058090051367× 1 unitBase unit28058090051361× 3 units58058090051362× 30 unitsIT-MF-000010069(01)08058090051367
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning 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 10 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 1, 2025 | Still on market |
| Cyprus | May 1, 2025 | Still on market |
| EL | May 1, 2025 | Still on market |
| Croatia | May 1, 2025 | Still on market |
| Ireland | May 1, 2025 | Still on market |
| Iceland | May 1, 2025 | Still on market |
| Malta | May 1, 2025 | Still on market |
| Poland | May 1, 2025 | Still on market |
| Slovenia | May 1, 2025 | Still on market |
| XI | May 1, 2025 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
M050101PLASTERS ON SPOOLS (ROLLS)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 →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 1984728 1IssuedITH 1984728 1SupplementedNotified 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 →Notified 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 →No certificate specifically references this device's Basic UDI-DI.