Identity
- Trade Name
- ECG Leadwires and trunk cables EUDAMEDGE Healthcare FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Leadwires and trunk cables EUDAMEDECG VALUE CABLE 10 LEAD CABLE/LDWR IEC FDA UDI
- Model / Reference
- 2104726-001 EUDAMEDFDA UDI
- Description
- ECG VALUE CABLE 10 LEAD CABLE/LDWR IEC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947437900104 EUDAMEDFDA UDI
- Basic UDI-DI
- 69474379DCARLeadwireJF EUDAMED
- Direct Marketing DI
- 06947437900104 EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Market of Registration
- Germany 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
GE Healthcare by Shenzhen Launch Electrical Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Launch Electrical Co., Ltd
Sources (2)
- FDA UDI b8241052-5a4e-4d4a-bc28-a69ea9dcc006 33 fields · synced Jun 19, 2026
- EUDAMED 67e6ae5e-d820-42a3-b1bf-71f77eb718df 61 fields · synced Jun 19, 2026