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ECG Lead Wires (3-Lead)
EUDAMEDClass I (EU MDR)
Ref P27628-02Model SONOSITE ECG MODULE
Identity
- Trade Name
- ECG Lead Wires (3-Lead) EUDAMED
- Device Name
- SONOSITE ECG MODULE EUDAMED
- Model / Reference
- SONOSITE ECG MODULE EUDAMEDP27628-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517106591 EUDAMED
- Basic UDI-DI
- 08415171ECGKTCB EUDAMED
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
ECG Lead Wires (3-Lead) by Fujifilm Sonosite, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171ECGKTCB | Class I | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (1)
- EUDAMED cf76766f-2133-4ffb-b28a-fc56d01080f0 61 fields · synced Jun 19, 2026