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Elektrody EKG
EUDAMEDClass I (EU MDR)
Ref EK-S 50 PSGModel EK-SRef EK-S 35 PRef EK-S 50 PRef EK-S 56 PRef EK-S 50 NWSGRef EK-S 60 PSG XCRef EK-S 62 PSG XCRef EK-S 56 PPG
Identity
- Trade Name
- Elektrody EKG EUDAMED
- Device Name
- Disposable ECG electrodes EUDAMED
- Model / Reference
- EK-S EUDAMEDEK-S 50 PSG EUDAMEDEK-S 35 P EUDAMEDEK-S 50 P EUDAMEDEK-S 56 P EUDAMEDEK-S 50 NWSG EUDAMEDEK-S 60 PSG XC EUDAMEDEK-S 62 PSG XC EUDAMEDEK-S 56 PPG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903002215531 EUDAMED05903002204955 EUDAMED05903002216552 EUDAMED05903002216590 EUDAMED05903002215784 EUDAMED05903002213049 EUDAMED05903002216682 EUDAMED05903002215753 EUDAMED05908212629307 EUDAMED
- Basic UDI-DI
- 5903002221125B 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
Elektrody EKG by SORIMEX sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
- ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
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- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Kendall — Cardinalhealth · 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 | 5903002221125B | Class I | Active |
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Manufacturer
- Manufacturer
- SORIMEX sp. z o.o.
- EUDAMED SRN
- PL-MF-000020958
Sources (9)
- EUDAMED 5a5bc07d-2ef0-4587-931c-ec2707f326e1 61 fields · synced Jul 29, 2026
- EUDAMED b9757137-ce06-4493-8d51-ce4a5c3c267d 61 fields · synced May 16, 2026
- EUDAMED 6301df91-d045-480d-b418-dd01db74374b 61 fields · synced May 16, 2026
- EUDAMED 012483cc-7f27-4c80-970d-604b8195f56e 61 fields · synced May 17, 2026
- EUDAMED 08567526-7a3d-4079-8ae0-2dc3ca7e7bd9 61 fields · synced May 17, 2026
- EUDAMED 93f91205-61f6-4245-965f-e0556743ac9b 61 fields · synced May 18, 2026
- EUDAMED 81107b2a-cdc9-4aa0-8721-ddd8ca6b5df6 61 fields · synced May 18, 2026
- EUDAMED 655bfa6a-ea79-4949-b3e6-ec1223c3b47b 61 fields · synced May 18, 2026
- EUDAMED 0039dad9-2a1d-4cb5-bb6b-924c11224455 61 fields · synced May 18, 2026