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DeepRhythm Platform

FDA UDI

Class II (US FDA UDI)

by Medicalgorithmics S.A.

Identity

Trade Name
DeepRhythm Platform FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Device Name
The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place. FDA UDI
Model / Reference
DeepRhythm Platform FDA UDI
Description
The DeepRhythm Platform is a modern cloud-based software system with microservice architecture and a browser-based user interface. It provides a comprehensive arrhythmia diagnosis process and monitoring session management capabilities, which consist of: • enrolling a patient for an ECG monitoring session in a medical facility, • receiving the signal from a compatible monitoring device worn by the patient, • using an external AI service for signal analysis and classification, • processing signal and annotations received from the external AI service, including statistics computation, • reviewing the signal and annotations by an ECG Technician, • generating and publishing reports for single ECG episodes and the entire monitoring session as well, • reviewing published reports back at the medical facility that ordered the monitoring session in the first place. FDA UDI

Identifiers

Primary DI / UDI-DI
05903021560698 FDA UDI
510(k) Number
K232161 FDA UDI
FDA Product Code
DPS FDA UDI
DQK FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording analyser application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2340 FDA UDI
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Electrocardiographic long-term ambulatory recording analyser application software

DeepRhythm Platform by Medicalgorithmics S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording analyser application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medicalgorithmics S.A.

Sources (1)

  • FDA UDI 75f8c4e3-1c3b-40ae-8ca1-955f6e15b77b 34 fields · synced May 31, 2026