Identity
- Trade Name
- TROPHYPAN EXCEL 3D ACCESS EUDAMED
- Device Name
- CS 8200 3D EUDAMED
- Model / Reference
- 5944905 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60192155944901 EUDAMED
- Basic UDI-DI
- 019215582003DSF EUDAMED
- EMDN Code
- Z11030302 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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 Excel 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 | 019215582003DSF | 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 f0969881-4660-448b-b53c-a5a1d20e9e1d 61 fields · synced Jul 24, 2026