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Cardiospy ECG Holter System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref EC-2H RecorderModel EC-2H System

by LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság

Identity

Trade Name
EC-2H Recorder EUDAMED
Cardiospy ECG Holter System FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser FDA UDI
Device Name
EC-2H System EUDAMED
The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. 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 EUDAMED
EC-2H Recorder EUDAMED
EC-2H FDA UDI
Description
The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for bluetooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. 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

Primary DI / UDI-DI
05999883490006 EUDAMEDFDA UDI
Basic UDI-DI
5999883490HOLTERSR9 EUDAMED
Direct Marketing DI
05999883490006 EUDAMED
510(k) Number
K140847 FDA UDI
FDA Product Code
MLO FDA UDI
EMDN Code
Z12050403 ECG HOLTER RECORDERS EUDAMED
GMDN Term
Electrocardiographic long-term ambulatory recording analyser FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 67.5 Millimeter FDA UDI
Width — 53 Millimeter FDA UDI
Width — 18.5 Millimeter FDA UDI
Weight — 50 Gram 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…

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording analyser.

Cleared under the same submission

K140847 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság

Sources (2)

  • FDA UDI a3a94da4-ed91-4593-bf03-d0928b75d1e7 35 fields · synced Jun 20, 2026
  • EUDAMED a5a1eb90-3680-43c4-b89b-6ba433044956 61 fields · synced Jun 20, 2026