Identity
- Trade Name
- SoloMobile FDA UDI
- Generic Name
- Mobile gamma camera system FDA UDI
- Device Name
- SoloMobile EUDAMEDGamma Camera System FDA UDI
- Model / Reference
- 9SOL2210-B05 EUDAMEDSoloMobile Gamma Camera System FDA UDI
- Description
- Gamma Camera System FDA UDI
Identifiers
- Catalog Number
- 9SOL2210 FDA UDI
- Primary DI / UDI-DI
- 05711665004009 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05711665004009 EUDAMED
- FDA Product Code
- IYX FDA UDI
- EMDN Code
- Z11020101 MOBILE GAMMA CAMERAS EUDAMED
- GMDN Term
- Mobile gamma camera system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1100 FDA UDI
- Market of Registration
- Denmark 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
Dimensions & Sizes
- Size
- Weight — 252 Kilogram FDA UDIHeight — 173 Centimeter FDA UDIDepth — 138 Centimeter FDA UDIWidth — 70 Centimeter FDA UDI
SoloMobile by Ddd-Diagnostic A/S — Class IIa — 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-05711665004009 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DDD-Diagnostic A/S
- EUDAMED SRN
- DK-MF-000009162
Sources (2)
- EUDAMED d646c4c8-00c3-4939-bb5b-502177f55c52 61 fields · synced Jul 30, 2026
- FDA UDI 0d4dd789-23e1-4e4e-8e86-0ae1cd5ca72e 36 fields · synced May 30, 2026