Identity
- Trade Name
- Holter Analysis Software FDA UDI
- Generic Name
- Cardiac arrhythmia monitoring system FDA UDI
- Device Name
- Holter Analysis Enhanced Plus FDA UDI
- Model / Reference
- Enhanced Plus FDA UDI
- Description
- Holter Analysis Enhanced Plus FDA UDI
Identifiers
- Catalog Number
- NEMK162 FDA UDI
- Primary DI / UDI-DI
- M581NEMK1620 FDA UDI
- 510(k) Number
- K930564 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiac arrhythmia monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac arrhythmia monitoring system
Holter Analysis Software by North East Monitoring, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- North East Monitoring, Inc.
Sources (2)
- FDA UDI db9ec4dd-5a29-41b4-b9c3-08e399329fea 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026