Identity
- Trade Name
- StarGuide EUDAMEDFDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- StarGuide EUDAMEDSTARGATE NM GANTRY FINAL FDA UDI
- Model / Reference
- H3911AA EUDAMEDH3911AB FDA UDI
- Description
- STARGATE NM GANTRY FINAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195278118295 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00195278118295 EUDAMED
- 510(k) Number
- K210173 FDA UDI
- FDA Product Code
- JAK FDA UDIKPS 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
- 892.1750 FDA UDI892.1200 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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 — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00195278118295 | 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 805b78ad-5694-41da-9da4-b57f7354408b 61 fields · synced Jul 16, 2026
- FDA UDI 4545d2f0-e576-47d3-8fd6-f7136cdfcbbe 34 fields · synced May 30, 2026