Identity
- Trade Name
- CT:VQ EUDAMED
- Device Name
- CT:VQ EUDAMED
- Model / Reference
- CT:VQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19356870000038 EUDAMED
- Basic UDI-DI
- 193568700CT:VQE3 EUDAMED
- EMDN Code
- Z11030699 COMPUTED TOMOGRAPHS (CT) - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Ct:vq by 4D Medical Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251484 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 193568700CT:VQE3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- 4D Medical Limited
- EUDAMED SRN
- AU-MF-000050621
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c5f85faa-6baa-43be-91a7-b90b77216a2c 61 fields · synced Jul 15, 2026
- FDA 510(k) K251484 1 fields · synced May 18, 2026