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HeartX Recorder Docking Station
EUDAMEDClass I (EU MDR)
Ref 86150 (Device without Packaging), 86151 (Device with GETEMED Packaging), 86151-IEM (Device with IEM Packaging) Model HeartX Recorder Docking Station
Identity
- Trade Name
- HeartX Recorder Docking Station EUDAMED
- Device Name
- HeartX Recorder Docking Station EUDAMED
- Model / Reference
- HeartX Recorder Docking Station EUDAMED86150 (Device without Packaging), 86151 (Device with GETEMED Packaging), 86151-IEM (Device with IEM Packaging) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250903203046 EUDAMED
- Basic UDI-DI
- 0425090320276NP EUDAMED
- Direct Marketing DI
- 04250903203046 EUDAMED
- EMDN Code
- Z12050480 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Electrocardiographic lead set, reusable
HeartX Recorder Docking Station by Getemed Medizin- Und Informationstechnik Ag — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0425090320276NP | Class I | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (2)
- EUDAMED 1776ef3b-24eb-4115-a3a1-5bf94cd97452 61 fields · synced Jun 19, 2026
- EUDAMED 1776ef3b-24eb-4115-a3a1-5bf94cd97452-1 61 fields · synced Jun 10, 2026