Identity
- Trade Name
- Aurora EUDAMED
- Device Name
- Aurora EUDAMED
- Model / Reference
- Aurora EUDAMEDH2412AL, H2412AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953017616 EUDAMED
- Basic UDI-DI
- 08406821BUG005717G EUDAMED
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aurora by GE Hualun Medical Systems 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 | 08406821BUG005717G | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE HUALUN MEDICAL SYSTEMS CO. Ltd
- EUDAMED SRN
- CN-MF-000001189
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 5e818a45-e10d-415e-b6ae-097a5ad11b40 61 fields · synced Jun 18, 2026
- EUDAMED 5e818a45-e10d-415e-b6ae-097a5ad11b40-1 61 fields · synced Jun 10, 2026