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Sh-48l
EUDAMEDClass I (EU MDR)
Ref 9744Model CS-B48-A\CS-B48-B\CS-B48-C\CS-B48-D\CS-B48-E\CS-B48-F\CS-B48-G\CS-B48-H\CS-B48-I\CS-B48-J\CS-B48-K\CS-B48-L
Identity
- Trade Name
- SH-48L EUDAMED
- Device Name
- Scanbody EUDAMED
- Model / Reference
- CS-B48-A\CS-B48-B\CS-B48-C\CS-B48-D\CS-B48-E\CS-B48-F\CS-B48-G\CS-B48-H\CS-B48-I\CS-B48-J\CS-B48-K\CS-B48-L EUDAMED9744 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970163089744 EUDAMED
- Basic UDI-DI
- 697016308HAFSIFTMR EUDAMED
- Direct Marketing DI
- 06970163089744 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
Sh-48l 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 | 697016308HAFSIFTMR | 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 0600377c-6bf2-4cb2-ac1c-89cdab4a03a8 61 fields · synced Jun 18, 2026