Identity
- Device Name
- Cubeholter Web EUDAMED
- Model / Reference
- 85039520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732653054 EUDAMED
- Basic UDI-DI
- B-08056732653054 EUDAMED
- EMDN Code
- Z12050482 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 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
Cubeholter Web 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-08056732653054 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (1)
- EUDAMED d3e37da7-808a-4de8-b57f-d49cd25da25c 61 fields · synced Jul 9, 2026