Identity
- Trade Name
- Ear Coupler Set FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Ear Coupler (PATH) EUDAMEDEar Coupler Set (25 pcs.) FDA UDI
- Model / Reference
- 100890-25 EUDAMEDFDA UDI
- Description
- Ear Coupler Set (25 pcs.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143427 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022ECC-1BM EUDAMED
- Unit of Use DI
- 04260223143410 EUDAMED
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- GWJ 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
- 882.1900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ear Coupler (PATH) 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 | 0426022ECC-1BM | 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 a72d531c-6312-4578-af70-fe050d3ecae9 61 fields · synced May 30, 2026
- FDA UDI 2d61e943-96f9-40f0-a76e-4571af7c28da 34 fields · synced May 30, 2026