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ECG Electrode
EUDAMEDClass I (EU MDR)
Ref CKC001A1Model CKC001A1、 CKC001A2、 CKC001B1、 CKC001B2、 CKC001C1、 CKC001C2、CKC011B、CKC013E、CKC012、CKC012B、CKC014C、CKC011、CKC005、CKC005B、CKC009、CKC011D、CKC007、CKC013BRef CKC001B2Ref CKC001C2
Identity
- Trade Name
- ECG Electrode EUDAMED
- Device Name
- ECG electrodes EUDAMED
- Model / Reference
- CKC001A1、 CKC001A2、 CKC001B1、 CKC001B2、 CKC001C1、 CKC001C2、CKC011B、CKC013E、CKC012、CKC012B、CKC014C、CKC011、CKC005、CKC005B、CKC009、CKC011D、CKC007、CKC013B EUDAMEDCKC001A1 EUDAMEDCKC001B2 EUDAMEDCKC001C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975319839013 EUDAMED06975319839044 EUDAMED06975319839068 EUDAMED
- Basic UDI-DI
- 697531983EE01KV EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
ECG Electrode by Shenzhen Ykd Technology Co., Ltd. — 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
- PG10S /RU26 — FIAB S.p.A. · Class I
- 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 | 697531983EE01KV | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Ykd Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017263
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED c425136a-51df-4e15-acb5-c1bcafbe217b 61 fields · synced Jul 23, 2026
- EUDAMED 21c399d6-75e2-4832-9201-faf1282ce4e2 61 fields · synced May 17, 2026
- EUDAMED f52dfd31-700a-4d00-adfa-6e90e946dab7 61 fields · synced May 17, 2026