Identity
- Trade Name
- Trophypan Smart 3D Access EUDAMED
- Device Name
- CS 8100 3D EUDAMED
- Model / Reference
- 5500384 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60192155500381 EUDAMED
- Basic UDI-DI
- 019215581003DS4 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 3D Access 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 | 019215581003DS4 | 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 e37a429b-e938-45d9-83d5-6adccb54038a 61 fields · synced Jun 19, 2026