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Cubestress System config. Package HD+ Blue
EUDAMEDClass IIa (EU MDR)
Ref KSSN00000-SL
Identity
- Device Name
- Cubestress System config. Package HD+ Blue EUDAMED
- Model / Reference
- KSSN00000-SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732651241 EUDAMED
- Basic UDI-DI
- B-08056732651241 EUDAMED
- EMDN Code
- Z12050101 STRESS ANALYSIS SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cubestress System config. Package HD+ Blue by Cardioline Spa — 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-08056732651241 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (1)
- EUDAMED 1af0d45a-85de-404e-be72-f9ffe60e2c79 61 fields · synced Jun 18, 2026