Identity
- Trade Name
- StarGuide FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- StarGuide EUDAMEDStarGuide NM GANTRY MDR FINAL FDA UDI
- Model / Reference
- StarGuide EUDAMEDH3911BH EUDAMEDH3911BJ FDA UDI
- Description
- StarGuide NM GANTRY MDR FINAL FDA UDI
Identifiers
- Catalog Number
- 5842898-10 FDA UDI
- Primary DI / UDI-DI
- 00195278755544 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00422HA EUDAMED
- 510(k) Number
- K210173 FDA UDI
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- EMDN Code
- Z11020201 CT/GAMMA CAMERA SYSTEMS EUDAMED
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
StarGuide by GE Medical Systems Israel, Functional Imaging — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00422HA | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (2)
- EUDAMED 766380ed-da0b-46f3-883e-8ef718eee9f9 61 fields · synced Jun 18, 2026
- FDA UDI 4f8190ba-24a8-4b3a-b387-b85191c8fbf9 35 fields · synced May 30, 2026