Identity
- Device Name
- ARi ExCon Implant EUDAMED
- Model / Reference
- ARIE324078M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809854028732 EUDAMED
- Basic UDI-DI
- 880972899218Q9 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
ARi ExCon Implant by Megagen Implant Co., Ltd. — Class IIb — 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 | 880972899218Q9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MegaGen Implant Co., Ltd.
- EUDAMED SRN
- KR-MF-000009885
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED a0c84046-f883-45e8-9d69-1d3f416821d6 61 fields · synced Jul 9, 2026