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Scan Ceph
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5500442Ref 5942404Ref CGK53Ref 5943246Ref 5314570Ref 5500434
Identity
- Trade Name
- SCAN CEPH EUDAMEDFDA UDI
- Generic Name
- Stationary cephalometric x-ray system, digital FDA UDI
- Device Name
- SCAN CEPH EUDAMEDSCAN CEPH UPGRADE FOR CS 8100 3D FDA UDI
- Model / Reference
- 5500442 EUDAMED5942404 EUDAMEDCGK53 EUDAMED5943246 EUDAMED5314570 EUDAMED5500434 EUDAMEDSCAN CEPH FDA UDI
- Description
- SCAN CEPH UPGRADE FOR CS 8100 3D FDA UDI
Identifiers
- Catalog Number
- 5500434 FDA UDI
- Primary DI / UDI-DI
- 60192155500442 EUDAMED60192155942402 EUDAMED60192155950537 EUDAMED60192155943249 EUDAMED60192155314575 EUDAMED60192155500435 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192155SCANCEPHRR EUDAMED
- FDA Product Code
- OAS FDA UDIMUH FDA UDI
- EMDN Code
- Z11030380 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - HARDWARE ACCESSORIES EUDAMEDZ11030302 EUDAMED
- GMDN Term
- Stationary cephalometric x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI872.1800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Scan Ceph by Carestream Dental LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0192155SCANCEPHRR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Carestream Dental LLC
- EUDAMED SRN
- US-MF-000003727
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (7)
- EUDAMED 36e12deb-13ad-4eae-969e-e5d55a967c24 61 fields · synced Jul 30, 2026
- EUDAMED e30e421f-8964-40b1-9f08-51583f1826bf 61 fields · synced May 17, 2026
- EUDAMED a7676aa4-de26-42ca-a3a8-f5cc13d76934 61 fields · synced May 17, 2026
- EUDAMED ec87a74e-7d67-4377-a185-ba8502acb2bc 61 fields · synced May 17, 2026
- EUDAMED e255da0a-3eae-4b2c-a2fd-c413d8342609 61 fields · synced May 17, 2026
- EUDAMED 8aa0f8ed-9169-42d2-bf32-7a9e019a171e 61 fields · synced May 18, 2026
- FDA UDI 99384e2d-2d81-4ff2-929a-4575f588abf3 34 fields · synced May 30, 2026