← Back to catalogue
Cra LF
EUDAMEDClass I (EU MDR)
Ref 9836Model 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
- Cra LF 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 EUDAMED9836 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970163089836 EUDAMED
- Basic UDI-DI
- 697016308AoralscanElf7V EUDAMED
- Direct Marketing DI
- 06970163089836 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
Cra LF 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shining 3D Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008402
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b0d280dc-b434-4402-a586-a82f1e9d504c 61 fields · synced Jul 11, 2026