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Cardiospy ECG Holter System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EC-12H/ABP V6 RecorderModel EC-2H System
by LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
Identity
- Trade Name
- EC-12H/ABP V6 Recorder EUDAMEDCardiospy ECG Holter System FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- EC-2H System EUDAMEDThe USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Cardiospy ECG Holter recorders (EC-2H, EC-3H or EC-12H) as a system and the management, procession and evaluation of the recorded row data. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality. FDA UDI
- Model / Reference
- EC-2H System EUDAMEDEC-12H/ABP V6 Recorder EUDAMEDUSB-02 Dongle FDA UDI
- Description
- The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Cardiospy ECG Holter recorders (EC-2H, EC-3H or EC-12H) as a system and the management, procession and evaluation of the recorded row data. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Export-import and archiving option of the recordings is available. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8, Windows 10 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality. FDA UDI
Identifiers
- Catalog Number
- DEV-00USB-02 FDA UDI
- Primary DI / UDI-DI
- 05999883490075 EUDAMEDFDA UDI
- Basic UDI-DI
- 5999883490HOLTERSR9 EUDAMED
- Direct Marketing DI
- 05999883490075 EUDAMED
- 510(k) Number
- K140847 FDA UDI
- FDA Product Code
- MLO FDA UDI
- EMDN Code
- Z12050402 MULTI–PARAMETER CARDIOVASCULAR HOLTER RECORDERS (ECG, NIPB, ETC.) EUDAMED
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- Hungary 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Weight — 50 Gram FDA UDIWidth — 18.5 Millimeter FDA UDIWidth — 53 Millimeter FDA UDILength — 67.5 Millimeter FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyser
Cardiospy ECG Holter System by LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság — Class II — MDR, FDA UDI — listed in FDA…
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Cleared under the same submission
K140847 also covers:
- Cardiospy ECG Holter System — LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
- Cardiospy ECG Holter System — LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
- Cardiospy ECG Holter System — LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI d03587e9-3fb5-4952-ba54-80857796d7c4 37 fields · synced Jun 18, 2026
- EUDAMED b407c979-0427-484f-b1da-581ca3ef7579 61 fields · synced Jun 18, 2026