Identity
- Trade Name
- Intraoral Scanbody EUDAMED
- Device Name
- Intraoral Scanbody EUDAMED
- Model / Reference
- OSHE031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809917607652 EUDAMED
- Basic UDI-DI
- 88000557ISBXH EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Intraoral Scanbody by ARUM DENTISTRY Co., Ltd. — 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 | 88000557ISBXH | Class I | Active |
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Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
- EUDAMED SRN
- KR-MF-000009313
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED cddcf63a-0765-47da-b353-d4c70c9c062b 61 fields · synced Jun 19, 2026