← Back to catalogue
Reusable ECG Electrode
EUDAMEDClass I (EU MDR)
Ref F1K2101Model F1K2101, F1K2102, F1K2103
Identity
- Device Name
- Reusable ECG Electrode EUDAMED
- Model / Reference
- F1K2101, F1K2102, F1K2103 EUDAMEDF1K2101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977704920122 EUDAMED
- Basic UDI-DI
- 697770492F1RECGETS EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Reusable ECG Electrode by Shenzhen F1 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
- Elektrody EKG — SORIMEX sp. z o.o. · Class I
- ECG — Zoll Medical Corporation · Class II
- 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
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 | 697770492F1RECGETS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen F1 Technology CO., Ltd
- EUDAMED SRN
- CN-MF-000043372
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 28024756-07b6-4fe5-8181-c6e54eb58674 61 fields · synced Jul 25, 2026