Identity
- Trade Name
- arcscan EUDAMED
- Device Name
- arcscan EUDAMED
- Model / Reference
- ARC-IOS100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809989880007 EUDAMED
- Basic UDI-DI
- 88099898ARC-IOS100DA EUDAMED
- Direct Marketing DI
- 08809989880007 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
arcscan by Arcreal Inc. — 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 | 88099898ARC-IOS100DA | Class I | Active |
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Manufacturer
- Manufacturer
- Arcreal Inc.
- EUDAMED SRN
- KR-MF-000043805
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 2f3cfea7-ec10-4bbe-b709-abab2f458a6b 61 fields · synced Jun 18, 2026