Identity
- Trade Name
- Intraoral Scanbody EUDAMED
- Device Name
- Intraoral Scanbody EUDAMED
- Model / Reference
- OSSQ049P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809955233998 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
Category: Dental implant suprastructure, temporary, preformed, single-use
The Intraoral Scanbody is a cutting-edge medical device used for precise intraoral scanning, providing high-quality 3D models of the mouth and surrounding tissues. This innovative tool has been designed to enhance patient care, improve treatment planning, and reduce surgical complications.
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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 099047ac-3185-4b3c-9869-e25d8b1a5397 61 fields · synced Jun 24, 2026