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ECG Disposable Lead wires
EUDAMEDFDA UDIClass I (EU MDR)
Ref A0001D03Ref A5157-EC1
Identity
- Trade Name
- ECG Disposable Lead wires EUDAMEDECG Lead wires EUDAMEDAPK FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDIElectrocardiographic lead set, single-use FDA UDI
- Device Name
- Disposable ECG Lead wires EUDAMEDECG Lead wires EUDAMEDCABLES FDA UDIECG Disposable Lead wires compatible with Nihon Kohden FDA UDI
- Model / Reference
- A0001D03 EUDAMEDFDA UDIA5157-EC1 EUDAMEDFDA UDI
- Description
- CABLES FDA UDIECG Disposable Lead wires compatible with Nihon Kohden FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946725527016 EUDAMEDFDA UDI06946725528020 EUDAMEDFDA UDI
- Basic UDI-DI
- 69467255A-DECG-cableZF EUDAMED69467255A-ECG-cableA6 EUDAMED
- 510(k) Number
- K170536 FDA UDI
- FDA Product Code
- IKD FDA UDIDSA FDA UDI
- EMDN Code
- Z12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDIElectrocardiographic lead set, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI870.2900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
ECG Disposable Lead wires by APK Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69467255A-DECG-cableZF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- APK Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000011581
- Authorised Representative
- Ruiyi Healthcare GmbH DE-AR-000005962
Sources (4)
- EUDAMED 3edfb2b4-3014-4316-ae72-d549638ebae6 61 fields · synced Jul 28, 2026
- FDA UDI 454194fa-78f3-4c52-a68d-89b79eb81183 33 fields · synced May 30, 2026
- FDA UDI 64fbf6b8-9509-4749-abb3-c635ae0c169b 34 fields · synced May 30, 2026
- EUDAMED d28b917c-2c78-427d-86da-0595886cffd3 61 fields · synced Jul 28, 2026