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Disposable ECG electrodes
EUDAMEDClass I (EU MDR)
Ref HT-XD-F01Model Specifications HT-XD-F01、HT-XD-F02、HT-XD-F03、HT-XD-F04、HT-XD-F05、HT-XD-F06、HT-XD-F07、HT-XD-F08、HT-XD-F09、HT-XD-F10、HT-XD-F11、HT-XD-F12、HT-XD-F13、HT-XD-F14、HT-XD-F15、HT-XD-F16、etc
Identity
- Device Name
- Disposable ECG electrodes EUDAMED
- Model / Reference
- Specifications HT-XD-F01、HT-XD-F02、HT-XD-F03、HT-XD-F04、HT-XD-F05、HT-XD-F06、HT-XD-F07、HT-XD-F08、HT-XD-F09、HT-XD-F10、HT-XD-F11、HT-XD-F12、HT-XD-F13、HT-XD-F14、HT-XD-F15、HT-XD-F16、etc EUDAMEDHT-XD-F01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944301303009 EUDAMED
- Basic UDI-DI
- 69443013HT01NA 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
Disposable ECG electrodes by Zhejiang Jinhua Huatong Medical Appliance 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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- 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 | 69443013HT01NA | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Jinhua Huatong Medical Appliance Co., Ltd
- EUDAMED SRN
- CN-MF-000010166
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 00eda7d9-f7b9-407f-8e27-6f846992a1bb 61 fields · synced Jul 19, 2026