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Aoralscan Elf (TS)
EUDAMEDClass I (EU MDR)
Ref 9409Model CS-A48-A，CS-A48-B，CS-A48-C，CS-A48-D，CS-A48-E，CS-A48-F，CS-A48-G，CS-A48-H，CS-A48-I，CS-A48-J，CS-A48-K,CS-A48-L,CS-A43-A,CS-A35-A,CS-A35-B，CS-A48M2-A
Identity
- Trade Name
- Aoralscan Elf (TS) EUDAMED
- Device Name
- Scanbody EUDAMED
- Model / Reference
- CS-A48-A，CS-A48-B，CS-A48-C，CS-A48-D，CS-A48-E，CS-A48-F，CS-A48-G，CS-A48-H，CS-A48-I，CS-A48-J，CS-A48-K,CS-A48-L,CS-A43-A,CS-A35-A,CS-A35-B，CS-A48M2-A EUDAMED9409 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970163089409 EUDAMED
- Basic UDI-DI
- 697016308AoralscanElf7V EUDAMED
- Direct Marketing DI
- 06970163089409 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
Yes
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 Elf (TS) 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 | 697016308AoralscanElf7V | 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 (1)
- EUDAMED e053ccd2-0075-4d76-b48f-cf2eea5e640f 61 fields · synced Jun 19, 2026