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StarGuide to StarGuide with dsCZT Detectors
EUDAMEDClass IIb (EU MDR)
Ref H3911CFModel StarGuide GX
Identity
- Trade Name
- StarGuide to StarGuide with dsCZT Detectors EUDAMED
- Device Name
- StarGuide GX EUDAMED
- Model / Reference
- StarGuide GX EUDAMEDH3911CF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953147122 EUDAMED
- Basic UDI-DI
- 08406821BUG0062278 EUDAMED
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
StarGuide to StarGuide with dsCZT Detectors by GE Medical Systems Israel, Functional Imaging — Class IIb — MDR — listed in EUDAMED
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 | 08406821BUG0062278 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems Israel, Functional Imaging
- EUDAMED SRN
- IL-MF-000003062
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED baa08978-0206-4bf2-8f74-9fac0ba0a83c 61 fields · synced Jun 18, 2026