Identity
- Trade Name
- StarGuide GX EUDAMED
- Device Name
- StarGuide GX EUDAMED
- Model / Reference
- StarGuide GX EUDAMEDH3911BW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953125540 EUDAMED
- Basic UDI-DI
- 08406821BUG0062278 EUDAMED
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
StarGuide GX by GE Medical Systems Israel, Functional Imaging — 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 | 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 c507400e-e11a-462f-87dd-bdd28deb4198 61 fields · synced Jun 19, 2026