Cardiovit AT-102 G2
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Schiller AG
Identity
- Trade Name
- CARDIOVIT AT-102 G2 EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- CARDIOVIT AT-102 G2 EUDAMEDThe CARDIOVIT AT-102 G2 is a 12-lead ECG device intended to be used by trained medical professionals in healthcare facilities for cardiological diagnosis in adult and paediatric patients. FDA UDI
- Model / Reference
- 3.912410 EUDAMEDFDA UDI
- Description
- The CARDIOVIT AT-102 G2 is a 12-lead ECG device intended to be used by trained medical professionals in healthcare facilities for cardiological diagnosis in adult and paediatric patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613365001860 EUDAMEDFDA UDI
- Basic UDI-DI
- 761336500000000758 EUDAMED
- Direct Marketing DI
- 07613365001860 EUDAMED
- 510(k) Number
- FDA Product Code
- DPS FDA 510(k)FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Cardiovit AT-102 G2 is a 12-channel electrocardiograph (ECG) device designed for recording and analyzing resting and exercise electrocardiograms. It provides real-time cardiac monitoring with high signal quality, supporting clinical assessments of cardiac function and rhythm disturbances.
This device is intended for use in general practitioner offices, clinics, and hospitals, featuring an 8-inch color touchscreen display and a sealed alphanumeric keyboard for easy cleaning and hygiene. Supplied as a reusable medical instrument, it complies with FDA 510(k) clearance and EU MDR regulations. Storage and maintenance follow manufacturer guidelines to ensure operational reliability.
Frequently asked questions
What types of ECG recordings can the Cardiovit AT-102 G2 perform, and where is it typically used?
The Cardiovit AT-102 G2 is designed for recording both resting and exercise electrocardiograms across 12 channels, enabling comprehensive cardiac monitoring. It is intended for use in general practitioner offices, clinics, and hospitals to assess cardiac function and rhythm disturbances in clinical settings.
Is the Cardiovit AT-102 G2 a single-use or reusable device, and what does that mean for maintenance?
The Cardiovit AT-102 G2 is a reusable medical instrument, meaning it is built for repeated use in clinical environments. To maintain reliability and hygiene, it must be cleaned and stored according to the manufacturer’s guidelines, which include proper care of the 8-inch color touchscreen and sealed alphanumeric keyboard.
What regulatory pathways has the Cardiovit AT-102 G2 followed, and what does that imply for its use?
The device has undergone FDA 510(k) clearance and complies with EU MDR regulations, confirming its safety and performance standards for use in the United States and European markets. This ensures it meets stringent requirements for clinical diagnostic equipment.
How does the design of the Cardiovit AT-102 G2 support clinical workflows and hygiene standards?
The device features an 8-inch color touchscreen and a sealed alphanumeric keyboard, both of which are designed for easy cleaning and maintenance. This ensures a hygienic environment for clinical use while supporting intuitive operation in fast-paced settings like offices, clinics, or hospitals.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CARDIOVIT AT-102 G2 - Schiller AG, CARDIOVIT AT-102 G2 - SCHILLER Americas %, SCHILLER CARDIOVIT AT-102 G2 USER MANUAL Pdf Download, CARDIOVIT AT-102 G2 ECG Machine - schillerservice.com, PDF CARDIOVIT AT-102 - schillerservice.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K183425 | Class II | Active |
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Manufacturer
- Manufacturer
- Schiller AG
Sources (3)
- FDA 510(k) K183425 24 fields · synced Sep 18, 2026
- FDA UDI e8b2e632-c602-4a9f-b5a1-2122e908d0e7 36 fields · synced May 30, 2026
- EUDAMED 09957a44-a0e3-4f8a-b3bb-095b70df2600 61 fields · synced Jun 20, 2026