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EUDAMED last updated this device on Jul 4, 2026
805347021OD006YYTNB.0010 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by GE.ME.S. GENERAL MEDICAL SUPPLIES S.R.L.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08053470219795TNB.0010(01)08053470219795
European Medical Device Nomenclature — the EU product classification assigned to this device.
P09120603CANNULATED SCREWS7 warnings recorded — scroll inside the panel to see all entries.
OTHER
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
IT-MF-000007779The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
OTHER
I Dispositivi di Osteosintesi sono monouso e non devono essere utilizzati più di una volta.
I Dispositivi di Osteosintesi non devono essere utilizzati e devono essere smaltiti secondo le indicazioni delle presenti IFU se la confezione è aperta o danneggiata. In aggiunta, nel caso di dispositivi sterili, la sterilità può esser stata compromessa.
Ogni utente è tenuto a leggere attentamente le istruzioni prima dell'uso.
I Dispositivi non sono progettati per l'avvitamento o la fissazione degli elementi posteriori della colonna vertebrale cervicale, toracica o lombare. I dispositivi non sono progettati per la sostituzione di funzioni complete e di sollecitazioni effettive delle ossa.
I Dispositivi di Osteosintesi non sono stati valutati per la sicurezza in ambiente RM. Non sono stati testati per il riscaldamento o il movimento indesiderato in ambiente RM. La sicurezza dei Dispositivi di Osteosintesi in ambiente RM è sconosciuta. L'esecuzione di un esame di risonanza magnetica su una persona che possiede questo dispositivo medico può provocare lesioni o malfunzionamenti del dispositivo.
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.
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 →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 →No certificate specifically references this device's Basic UDI-DI.
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 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.