Identity
- Trade Name
- Cardionica Patch EUDAMED
- Model / Reference
- MIR066 Accessories EUDAMED912004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990322107 EUDAMED
- Basic UDI-DI
- 805299032066P56 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Electrocardiographic electrode, single-use
Cardionica Patch by MIR - Medical International Research S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805299032066P56 | Class I | Active |
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Manufacturer
- Manufacturer
- MIR - Medical International Research S.p.A.
- EUDAMED SRN
- IT-MF-000014026
Sources (1)
- EUDAMED 38cbaa11-d6f5-4611-be5d-051fd7d6d5ca 61 fields · synced Jun 18, 2026