Identity
- Trade Name
- DR400 EUDAMED
- Device Name
- NorthEast DR400 Holter Recorder EUDAMED
- Model / Reference
- DR400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M582DR4004G EUDAMED
- Basic UDI-DI
- B-M582DR4004G EUDAMED
- EMDN Code
- C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Dr400 by North East Monitoring, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-M582DR4004G | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NorthEast Monitoring, Inc.
- EUDAMED SRN
- US-MF-000019819
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 754bdb2b-bb05-4331-b278-7270b3eb4357 61 fields · synced Oct 6, 2026