Identity
- Trade Name
- DR400 FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- DR400 holter recorder with NEMEL002/003 patches FDA UDI
- Model / Reference
- DR400 FDA UDI
- Description
- DR400 holter recorder with NEMEL002/003 patches FDA UDI
Identifiers
- Catalog Number
- NEMK157 FDA UDI
- Primary DI / UDI-DI
- M581NEMK1570 FDA UDI
- 510(k) Number
- K142424 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 6.7 Centimeter FDA UDIWidth — 3.8 Centimeter FDA UDIDepth — 1.2 Centimeter FDA UDIWeight — 35 Gram FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyser
Dr400 by North East Monitoring, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic long-term ambulatory recording analyser.
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- SYNECOM — MICROPORT CRM SRL · Class II
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- CardioCard Holter — NASIFF ASSOCIATES INC · Class II
Cleared under the same submission
K142424 also covers:
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 a3d1c2f2-ec07-4bea-8805-958f8f65792d 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026