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FinScan F360D
EUDAMEDClass IIb (EU MDR)
Ref MMA36001 for FinScan F360D (with CEPH) MMA36006 for FinScan F360D (without CEPH)
Identity
- Trade Name
- FinScan F360D EUDAMED
- Device Name
- Dental Cone-beam Computed Tomography System EUDAMED
- Model / Reference
- MMA36001 for FinScan F360D (with CEPH) MMA36006 for FinScan F360D (without CEPH) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117940024 EUDAMED
- Basic UDI-DI
- 697611794FY001JD EUDAMED
- Direct Marketing DI
- 06976117940024 EUDAMED
- EMDN Code
- Z110312 CONE BEAM COMPUTED TOMOGRAPHS (CBCT) EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
FinScan F360D by Changzhou Finno Medical Technology Co., Ltd. — 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 | 697611794FY001JD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Changzhou Finno Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000043302
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED bea1fa08-e792-4d43-8c28-7eb87eddc255 61 fields · synced Jul 21, 2026