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EUDAMED last updated this device on Jul 5, 2024
++M483L091104F9ROTAX TRIAL HEMI WEDGE S3 H10 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by groupe lépine. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
+M483GRAHC3100GRAHC310+M483GRAHC3100
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
L091104ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLEPrimary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
FR-MF-000001182Sterile
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 →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 →++M483L091104F9On the marketROTAX TRIAL HEMI WEDGE S2 H10++M483L091104F9On the marketROTAX TRIAL HEMI WEDGE S3 H05++M483L091104F9On the marketROTAX TRIAL PATELLA S1++M483L091104F9On the marketROTAX TRIAL PATELLA S2++M483L091104F9On the marketROTAX TRIAL PATELLA S3++M483L091104F9On the marketNo 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.