Identity
- Trade Name
- myoncare EUDAMEDFDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Careplan Manager EUDAMED
- Model / Reference
- ON01010113 EUDAMED1.12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260658860203 EUDAMEDFDA UDI
- Basic UDI-DI
- 42606588644781952684300AP EUDAMED
- Direct Marketing DI
- 04260658860203 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
myoncare by ONCARE GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42606588644781952684300AP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ONCARE GmbH
- EUDAMED SRN
- DE-MF-000007460
Sources (2)
- EUDAMED 7fd659d5-2c32-4989-a763-d298f0dbd6b2 61 fields · synced Jun 8, 2026
- FDA UDI 88d6ca1b-f9be-474a-94ad-f5f920d9d07f 32 fields · synced May 30, 2026