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PocketECG IV – Unified Arrhythmia Diagnostic System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 05903021560377Model P4TR-CE-ADSRef 05903021560315Ref 05903021560278
Identity
- Trade Name
- PocketECG IV EUDAMEDPocketECG IV – Unified Arrhythmia Diagnostic System FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- Unified Arrhythmia Diagnostic System PocketECG IV EUDAMEDThe battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the P4BA-AA-UNI or P4BA-AB-UNI batteries used with PocketECG transmitter. FDA UDI
- Model / Reference
- P4TR-CE-ADS EUDAMED05903021560377 EUDAMED05903021560315 EUDAMED05903021560278 EUDAMEDP3CH-AB-UNI FDA UDI
- Description
- The battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the P4BA-AA-UNI or P4BA-AB-UNI batteries used with PocketECG transmitter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05903021560377 EUDAMED05903021560315 EUDAMED05903021560278 EUDAMED05903021560100 FDA UDI
- Basic UDI-DI
- 590302156PECGT-IVMG EUDAMED
- Direct Marketing DI
- 05903021560377 EUDAMED05903021560315 EUDAMED05903021560278 EUDAMED
- 510(k) Number
- K193104 FDA UDI
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Sweden EUDAMEDAustria EUDAMEDPoland 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
Category: Electrocardiography telemetric monitoring system
PocketECG IV – Unified Arrhythmia Diagnostic System by Medicalgorithmics S.A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Electrocardiography telemetric monitoring system.
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- RhythmStar — RhythMedix, LLC · Class II
Cleared under the same submission
K193104 also covers:
- Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG — 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 (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
- Manufacturer
- Medicalgorithmics S.A.
Sources (4)
- FDA UDI a10e130d-9435-45b3-ba68-52131ddbfb04 34 fields · synced Aug 3, 2026
- EUDAMED 9d81f6e5-d6dd-44ad-b10c-186912d35ea4 61 fields · synced Jul 27, 2026
- EUDAMED d56e8881-a783-4679-b401-8c2453295b64 61 fields · synced Aug 2, 2026
- EUDAMED 5a196053-6b42-4ed9-8ff8-b332c0195de4 61 fields · synced Aug 3, 2026