Identity
- Trade Name
- myoncare EUDAMED
- Device Name
- Mobile EUDAMEDCareplan Manager EUDAMED
- Model / Reference
- ON01039914 EUDAMEDON01010114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260658860241 EUDAMED04260658860234 EUDAMED
- Basic UDI-DI
- 426065886947238412232007H EUDAMED42606588644781952684300AP EUDAMED
- Direct Marketing DI
- 04260658860241 EUDAMED04260658860234 EUDAMED
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMEDZ12040192 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
myoncare by ONCARE GmbH — 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 | 426065886947238412232007H | Class IIa | Active |
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Manufacturer
- Manufacturer
- ONCARE GmbH
- EUDAMED SRN
- DE-MF-000007460
Sources (2)
- EUDAMED 3b75b2f7-23f1-42a2-9f21-d85d155757c8 61 fields · synced Jul 24, 2026
- EUDAMED 8d262e1f-4a0a-40a4-b908-b0d58bf55b61 61 fields · synced May 18, 2026