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Head Auto Views
EUDAMEDClass IIa (EU MDR)
Ref 5988228Model Head Auto ViewsRef 5973666
Identity
- Trade Name
- Head Auto Views EUDAMED
- Device Name
- Head Auto Views EUDAMED
- Model / Reference
- Head Auto Views EUDAMED5988228 EUDAMED5973666 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953067543 EUDAMED00195278932365 EUDAMED
- Basic UDI-DI
- 8406821BUG00411H5 EUDAMED
- Direct Marketing DI
- 00198953067543 EUDAMED00195278932365 EUDAMED
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMEDZ11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
Category: Full-body CT system
Head Auto Views by GE Medical Systems, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8406821BUG00411H5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 1bb48078-c1a2-4503-a086-329da1925bd9 61 fields · synced Jul 9, 2026
- EUDAMED ea3d6d64-d7c2-4c8f-af41-1b3ff0de9b14 61 fields · synced May 19, 2026