Identity
- Trade Name
- MyoSPECT ES EUDAMEDFDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- MyoSPECT EUDAMEDMyoSPECT ES MDR GANTRY FDA UDI
- Model / Reference
- MyoSPECT EUDAMEDH3912BD EUDAMEDFDA UDI
- Description
- MyoSPECT ES MDR GANTRY FDA UDI
Identifiers
- Catalog Number
- 5875815-40 FDA UDI
- Primary DI / UDI-DI
- 00195278488626 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00251H7 EUDAMED
- 510(k) Number
- K212004 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020104 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION EUDAMED
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- Türkiye 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
No
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
MyoSPECT ES by GE Medical Systems Israel, Functional Imaging — Class IIa — 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 | 8406821BUG00251H7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 0052c69d-dd3d-4b9a-a30b-be83c59899fe 61 fields · synced Jun 19, 2026
- FDA UDI 85be9c17-9f84-4726-bef7-fe24ba6e7a33 35 fields · synced May 30, 2026