Identity
- Trade Name
- Trophypan Smart SC 3D EUDAMED
- Device Name
- CS 8100SC 3D EUDAMED
- Model / Reference
- 5500244 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60192155500244 EUDAMED
- Basic UDI-DI
- 01921558100SC3DH2 EUDAMED
- EMDN Code
- Z11030302 EUDAMED
Classification
- Device Class
- Class IIb 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
Trophypan Smart SC 3D by Carestream Dental LLC — Class IIb — 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 | 01921558100SC3DH2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Carestream Dental LLC
- EUDAMED SRN
- US-MF-000003727
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (1)
- EUDAMED fdfe0e55-cb93-4840-aab9-ca2d70ae34f2 61 fields · synced Jun 17, 2026