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ECG Cable Assembly and Module
EUDAMEDFDA UDIClass I (EU MDR)
Ref P29189-01Model SONOSITE ECG MODULE
Identity
- Trade Name
- ECG Cable Assembly and Module 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 EUDAMEDP29189-01 EUDAMED1 FDA UDI
- Description
- Diagnostic Ultrasound System Accessory FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841517106805 EUDAMEDFDA UDI
- 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
- 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 Cable Assembly and Module 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 48467970-5a62-496d-a346-03a6435ed640 61 fields · synced Jul 10, 2026
- FDA UDI 8e521156-b978-4dfe-90e3-05cbf58ba19b 35 fields · synced May 30, 2026