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ECG Leadwires - 5 Lead - Pinch Type - 50" (127cm) – IEC
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0012-00-1813-02Model Cardiosave
Identity
- Trade Name
- ECG Leadwires - 5 Lead - Pinch Type - 50" (127cm) – IEC EUDAMEDCABLE,ECG LEAD SET,5L,50",IEC FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Cardiosave EUDAMEDCABLE,ECG LEAD SET,5L,50",IEC FDA UDI
- Model / Reference
- Cardiosave EUDAMED0012-00-1813-02 EUDAMEDFDA UDI
- Description
- CABLE,ECG LEAD SET,5L,50",IEC FDA UDI
Identifiers
- Catalog Number
- 0012-00-1813-02 FDA UDI
- Primary DI / UDI-DI
- 10607567112244 EUDAMEDFDA UDI
- Basic UDI-DI
- 10607IABPaccessoriesBW EUDAMED
- FDA Product Code
- DSP FDA UDI
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3535 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Inch FDA UDI
ECG Leadwires - 5 Lead - Pinch Type - 50" (127cm) – IEC by Datascope Corp. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 10607IABPaccessoriesBW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Datascope Corp
- EUDAMED SRN
- US-MF-000015587
- Authorised Representative
- MAQUET Critical Care AB SE-AR-000001442
Sources (2)
- EUDAMED cd08ac8a-a2f2-4ff8-9ba7-68d492bb649a 61 fields · synced Oct 6, 2026
- FDA UDI 10133983-eb3c-41ed-af16-99d452cfc971 36 fields · synced May 30, 2026