Identity
- Device Name
- Solo EUDAMED
- Model / Reference
- 9SOL2225-B03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05711665022256 EUDAMED
- Basic UDI-DI
- B-05711665022256 EUDAMED
- EMDN Code
- Z11020102 FIXED STATION GAMMA CAMERAS WITH SINGLE HEAD - WITHOUT ‘TOTAL BODY' ACQUISITION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Solo by Ddd-Diagnostic A/S — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05711665022256 | Class IIa | Active |
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Manufacturer
- Manufacturer
- DDD-Diagnostic A/S
- EUDAMED SRN
- DK-MF-000009162
Sources (1)
- EUDAMED 2619d27e-dc36-4e58-bcb3-6999707dfcd0 61 fields · synced Jun 18, 2026