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Aramis Trial Insert Ø38 +12
EUDAMEDClass IIa (EU MDR)
Ref EAA IE12Model Orthopaedic prostheses positioners, reusable
Identity
- Trade Name
- ARAMIS TRIAL INSERT Ø38 +12 EUDAMED
- Device Name
- Orthopaedic prostheses positioners, reusable EUDAMED
- Model / Reference
- Orthopaedic prostheses positioners, reusable EUDAMEDEAA IE12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483EAAIE120 EUDAMED
- Basic UDI-DI
- ++M483L091104F9 EUDAMED
- Direct Marketing DI
- +M483EAAIE120 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Discover the ARAMIS TRIAL INSERT Ø38 +12, a Class IIa medical device used for the positioning of orthopaedic prostheses. This device is designed to provide a sterile and safe environment for implantation, ensuring optimal results for patients.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M483L091104F9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED eb9c62dd-5f43-46b0-ac8e-179314c7e99c 61 fields · synced Jul 21, 2026