Identity
- Trade Name
- Intraoral Scanbody Screw EUDAMED
- Device Name
- Intraoral Scanbody EUDAMED
- Model / Reference
- OSSH141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809950311462 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 Screw is a medical device designed for intraoral scans, providing high-resolution images of the oral cavity. It's an essential tool in dental clinics and surgeons' offices for diagnosing oral conditions, developing surgical plans, and ensuring proper treatment.
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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 43396b3f-cd0c-4391-9233-9a249a5bcebc 61 fields · synced Jul 26, 2026