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Ultragel
EUDAMEDClass I (EU MDR)
Ref ELECTRODE F5035NEWRef ELECTRODE F30Ref ELECTRODE FS50Ref ELECTRODE EEE116
Identity
- Trade Name
- Ultragel EUDAMED
- Device Name
- ECG Electrode EUDAMED
- Model / Reference
- ELECTRODE F5035NEW EUDAMEDELECTRODE F30 EUDAMEDELECTRODE FS50 EUDAMEDELECTRODE EEE116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903246098341 EUDAMED05903246098297 EUDAMED05903246098365 EUDAMED05903246098372 EUDAMED
- Basic UDI-DI
- 5903246098ECGELECTRODEXB EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
Ultragel by Esvico Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (4)
- EUDAMED 92966ad2-39b1-4b1b-bcdd-bf643a96a449 61 fields · synced Jul 27, 2026
- EUDAMED fbebcfea-ea46-4138-a517-ad625498c04b 61 fields · synced May 17, 2026
- EUDAMED 767d355a-ee72-43f1-aa1d-0d497b29c0bf 61 fields · synced May 19, 2026
- EUDAMED 7cd2e9c2-d698-4e9d-8188-094de01aa544 61 fields · synced May 19, 2026