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ECG Lead Wires (3-Lead)
EUDAMEDFDA UDIClass I (EU MDR)
Ref P30131-02Model SONOSITE ECG MODULE
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 EUDAMEDP30131-02 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound System Accessory FDA UDI
Identifiers
- Catalog Number
- P30131 FDA UDI
- Primary DI / UDI-DI
- 00841517110314 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171ECGKTCB EUDAMED
- 510(k) Number
- K233597 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO 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 (2)
- EUDAMED 1d9997e1-b322-4cc6-ac45-449db8e22ef6 61 fields · synced Jul 27, 2026
- FDA UDI 5f979850-0e77-4cdb-9b77-1bbeba356015 36 fields · synced May 30, 2026