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Analysis Software
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Holter LX Analysis510(k) K081861
Identity
- Trade Name
- Analysis Software EUDAMED
- Device Name
- Analysis Software EUDAMED
- Model / Reference
- Holter LX Analysis EUDAMED
Identifiers
- Primary DI / UDI-DI
- M582AnalysisSoftwareH4 EUDAMED
- Basic UDI-DI
- B-M582AnalysisSoftwareH4 EUDAMED
- EMDN Code
- C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Analysis Software by North East Monitoring, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081861 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-M582AnalysisSoftwareH4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- NorthEast Monitoring, Inc.
- EUDAMED SRN
- US-MF-000019819
- FDA Applicant
- North East Monitoring, Inc.
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 1ce4d4c1-b873-47b2-9fbd-852e1c097f72 85 fields · synced Jun 18, 2026
- FDA 510(k) K081861 1 fields · synced May 18, 2026