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Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- The PC Client software is an accessory to the Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III and Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors. FDA UDI
- Model / Reference
- Type: PC Client FDA UDI
- Description
- The PC Client software is an accessory to the Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III and Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05903021560001 FDA UDI
- FDA Product Code
- DSI FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG by Medicalgorithmics S.A. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K124060 also covers:
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
K152550 also covers:
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
K173969 also covers:
K193104 also covers:
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
- PocketECG IV – Unified Arrhythmia Diagnostic System — Medicalgorithmics S.A.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medicalgorithmics S.A.
Sources (1)
- FDA UDI db7b7412-7397-4ce0-b3a3-2283e3ad4982 34 fields · synced Jun 6, 2026