Identity
- Trade Name
- PATH Ear Coupler Cable EUDAMEDEar Coupler Cable FDA UDI1077 EAR COUPLER CABLE FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Ear Coupler Cable EUDAMEDEar Coupler Cable (PECC-01) FDA UDI
- Model / Reference
- 100477 EUDAMEDFDA UDIECC EUDAMED8-69-41200 FDA UDI
- Description
- Ear Coupler Cable (PECC-01) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143083 EUDAMEDFDA UDI04260223141386 FDA UDI
- Basic UDI-DI
- 0426022ECC-2a5Z EUDAMED
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- EMDN Code
- Z12140302 EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class IIa 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
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
Category: Evoked-potential audiometer
Ear Coupler Cable by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
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- ABR Test Cavity — Otodynamics · Class II
Cleared under the same submission
K133012 also covers:
- AuDX Device with touchscreen — PATH medical GmbH
- AuDX PRO FLEX Device with touchscreen — PATH medical GmbH
- Bone Conductor B71W — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Bone Conductor B81 — PATH medical GmbH
- Ear Coupler Cable — PATH medical GmbH
- Ear Coupler Set — PATH medical GmbH
- Ear Tip IT-02 Pack/100 pcs. — PATH medical GmbH
- Ear Tip IT-03 Pack/100 pcs. — PATH medical GmbH
- Headphone DD-45 contra — PATH medical GmbH
- Headphone DD-65 — PATH medical GmbH
- Headphone HDA 280 — PATH medical GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (3)
- FDA UDI 117104ae-e153-4b80-9b99-5fb9e37ed1c5 34 fields · synced Jul 9, 2026
- FDA UDI ece21766-0c05-43ca-9971-3e0d111916e6 32 fields · synced May 29, 2026
- EUDAMED 7d55b1c3-5e16-4df1-aebf-4943bd506861 61 fields · synced Jul 9, 2026