Identity
- Trade Name
- Ordamed EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- Amulet 48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903246098518 EUDAMED
- Basic UDI-DI
- 5903246098ECGELECTRODEXB EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 electrode, single-use
Ordamed by Esvico Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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- Medline — MEDLINE INDUSTRIES, 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 | 5903246098ECGELECTRODEXB | Class I | Active |
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Manufacturer
- Manufacturer
- Esvico Sp. z o.o.
- EUDAMED SRN
- PL-MF-000022702
Sources (1)
- EUDAMED de266a03-971b-4d6c-b964-26e50e19fce7 61 fields · synced Jun 18, 2026