Identity
- Trade Name
- Electrode Cable FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- ABR Electrode Cable EUDAMED
- Model / Reference
- EC-02 EUDAMED100307 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141003 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022ElectrodeCable-13U EUDAMED
- Direct Marketing DI
- 04260223141003 EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z12140380 EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Evoked-potential audiometer 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ABR Electrode Cable by PATH medical GmbH — 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 | 0426022ElectrodeCable-13U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PATH MEDICAL GmbH
- EUDAMED SRN
- DE-MF-000006935
Sources (2)
- EUDAMED 1619b433-787e-4636-8a01-b3434ed64d57 61 fields · synced Jul 10, 2026
- FDA UDI 0dd8db8a-af2b-49d4-a670-5ad33e4f8e11 32 fields · synced May 30, 2026