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Aoralscan Elite Wireless
EUDAMEDClass I (EU MDR)
Ref 9270Model Aoralscan Elite WirelessRef 9973
Identity
- Trade Name
- Aoralscan Elite Wireless EUDAMED
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- Aoralscan Elite Wireless EUDAMED9270 EUDAMED9973 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970163089270 EUDAMED06970163089973 EUDAMED
- Basic UDI-DI
- 697016308AoralscanEWFM EUDAMED
- Direct Marketing DI
- 06970163089270 EUDAMED06970163089973 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Aoralscan Elite Wireless by Shining 3D Tech 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 | 697016308AoralscanEWFM | Class I | Active |
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Manufacturer
- Manufacturer
- Shining 3D Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008402
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4463d1db-1025-46af-9180-6886a0d6597c 61 fields · synced Jul 27, 2026
- EUDAMED dfefb2ce-315c-40ae-b69f-929f996f94f6 61 fields · synced May 18, 2026