Identity
- Trade Name
- icompanion EUDAMED
- Device Name
- icompanion EUDAMED
- Model / Reference
- 2.2.z EUDAMED2.1.z EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B621ICOMPANION2X2Y0 EUDAMED+B621ICOMPANION2X1Y0 EUDAMED
- Basic UDI-DI
- ++B621ICOMPANION24F EUDAMED
- Direct Marketing DI
- +B621ICOMPANION2X2Y0 EUDAMED+B621ICOMPANION2X1Y0 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
icompanion by icometrix — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++B621ICOMPANION24F | Class IIa | Active |
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Manufacturer
- Manufacturer
- icometrix
- EUDAMED SRN
- BE-MF-000006329
Sources (2)
- EUDAMED c41ff3da-6a5e-4bf8-93f9-df22723113c5 61 fields · synced Jul 15, 2026
- EUDAMED db01b6af-6681-438b-aaf5-f8f35aa110db 61 fields · synced May 18, 2026