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ECG Lead Wires (3-Lead)
EUDAMEDFDA UDIClass I (EU MDR)
Ref P30130-01Model SONOSITE ECG MODULERef P31048-01Ref P31047-01Ref P31047-02
Identity
- Trade Name
- ECG Lead Wires (3-Lead) EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- SONOSITE ECG MODULE EUDAMEDDiagnostic Ultrasound System Accessory FDA UDI
- Model / Reference
- SONOSITE ECG MODULE EUDAMEDP30130-01 EUDAMEDP31048-01 EUDAMEDP31047-01 EUDAMEDP31047-02 EUDAMED1 FDA UDI
- Description
- Diagnostic Ultrasound System Accessory FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841517106782 EUDAMEDFDA UDI00841517108427 EUDAMED00841517108403 EUDAMED00841517111489 EUDAMED
- Basic UDI-DI
- 08415171ECGKTCB EUDAMED
- 510(k) Number
- K200964 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDIOIJ FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ECG Lead Wires (3-Lead) by Fujifilm Sonosite, Inc. — 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 | 08415171ECGKTCB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (5)
- EUDAMED c0c88a48-1fe5-4760-82d6-0f60737e361f 61 fields · synced Jul 27, 2026
- EUDAMED edb8bbab-3cb8-46b6-a852-391dd8926f0f 61 fields · synced May 16, 2026
- EUDAMED 10d602a5-69d0-4a7c-82a2-7c2ac9dcc4e1 61 fields · synced May 18, 2026
- EUDAMED c4442512-5da4-4cce-9f8c-f303133e8afa 61 fields · synced May 18, 2026
- FDA UDI 0018dacf-d8eb-473e-bd0f-eac944faa003 35 fields · synced May 29, 2026