Identity
- Trade Name
- Intraoral Scanbody Screw EUDAMED
- Device Name
- Intraoral Scanbody EUDAMED
- Model / Reference
- OSST017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800055773773 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
The Intraoral Scanbody Screw is a cutting-edge medical device designed for precision dental imaging. It offers accurate and high-resolution scans of teeth, allowing dentists to diagnose and treat various oral health issues effectively. The device's ability to scan intraorally enables precise measurements and diagnoses that can be used to guide treatment plans. By providing detailed images of teeth, it facilitates more effective patient care.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
- EUDAMED SRN
- KR-MF-000009313
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED 8024dbbb-a6b6-4bbf-8b22-0d2e2363dd7b 61 fields · synced Aug 2, 2026