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CardioDay
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2092504-270Model CardioDay510(k) K051471
Identity
- Trade Name
- CardioDay EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- CardioDay v2.x EUDAMEDThe CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. FDA UDI
- Model / Reference
- CardioDay EUDAMED2092504-270 EUDAMEDv2.7 Global FDA UDI
- Description
- The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. FDA UDI
Identifiers
- Catalog Number
- 2092504-270 FDA UDI
- Primary DI / UDI-DI
- 04250903202520 EUDAMEDFDA UDI
- Basic UDI-DI
- 0425090320240N2 EUDAMED
- 510(k) Number
- K162023 FDA UDI
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z12050492 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CardioDay by Getemed Medizin- Und Informationstechnik Ag — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051471 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K130516 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0425090320240N2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (3)
- EUDAMED cbeaff60-d572-43ee-95e0-19216564d5f1 85 fields · synced Jun 19, 2026
- FDA UDI e418026f-49ba-4b7b-a09d-1935a8a8e1b6 35 fields · synced May 30, 2026
- FDA 510(k) K051471 1 fields · synced May 18, 2026