Identity
- Trade Name
- ALFA 2-IN-1 3D FACIAL SCANNER EUDAMEDALFA 2-IN-1 3D FACIAL SCANNER EUDAMED
- Device Name
- Alfa Facial Scanner EUDAMED
- Model / Reference
- FSJMA-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976052180025 EUDAMED06976052180028 EUDAMED
- Basic UDI-DI
- 697605218FSJMA01U4 EUDAMED
- Direct Marketing DI
- 06976052180028 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
Alfa 2-In-1 3d Facial Scanner by Shanghai Shecheng Medical Device 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 | 697605218FSJMA01U4 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Shecheng Medical Device Co., LTD.
- EUDAMED SRN
- CN-MF-000046122
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (2)
- EUDAMED bd6ee3aa-c5e7-4820-9d19-1b86c05307cf 61 fields · synced Jul 30, 2026
- EUDAMED 6e7e3631-048b-4df1-a58e-9944bbc5e612 61 fields · synced May 19, 2026