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Articulation Omega Ext Dr
EUDAMEDClass I (EU MDR)
Ref PU4I-1EDModel Articulations de genou
by Janton (g2m)
Identity
- Trade Name
- ARTICULATION OMEGA EXT DR EUDAMED
- Model / Reference
- Articulations de genou EUDAMEDPU4I-1ED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03666322203542 EUDAMED
- Basic UDI-DI
- 3666322ORTAGENOUS4 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Articulation Omega Ext Dr by Janton (g2m) — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 3666322ORTAGENOUS4 | Class I | Active |
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Manufacturer
- Manufacturer
- Janton (g2m)
- EUDAMED SRN
- FR-MF-000003877
Sources (1)
- EUDAMED f51b4575-2bc0-4568-af4b-6be3211f2016 61 fields · synced Jul 13, 2026