Identity
- Trade Name
- Intraoral Scanbody EUDAMED
- Device Name
- Intraoral Scanbody EUDAMED
- Model / Reference
- OSH5509R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800055783314 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
Unlock the future of dental diagnostics with MedNet EC-REP IIb GmbH's Intraoral Scanbody, a cutting-edge medical device that combines advanced scanning technology with AI-powered analysis to provide accurate diagnoses and precise treatment planning.
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- US Fixture Transfer Impression Coping — OSSTEM IMPLANT Co., Ltd. · Class I
- Unodent — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Implantium, Superline — Dentium Co., Ltd. · Class II
- SmartFlag by APOLLO — APOLLO IMPLANT COMPONENTS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ · Class I
- Healing Abutment — Megagen Implant Co. Ltd · Class II
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 5c08ded7-e121-4699-958c-6ea72e404381 61 fields · synced Jul 15, 2026