Identity
- Trade Name
- ET-13 EUDAMEDEar Tip ET-13 Pack/100 pcs. FDA UDI1077 EARTIP 8-11 TRANS 100 PCS FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Ear Tips for Ear Probes EUDAMED
- Model / Reference
- 100144-100 EUDAMEDFDA UDI8-68-34510 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223145353 EUDAMEDFDA UDI04260223141874 FDA UDI
- Basic UDI-DI
- 0426022Probes-16B EUDAMED
- FDA Product Code
- GWJ FDA UDIETT FDA UDI
- EMDN Code
- Z12140380,Z12149001 EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI874.1100 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
Ear Tip ET-13 Pack/100 pcs. by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Evoked-potential audiometer.
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- ABR Test Cavity — Otodynamics · Class II
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 36de66c4-ad9c-40e0-b3c4-1810321abb24 32 fields · synced Jul 9, 2026
- FDA UDI de8db6ed-3487-46e0-8858-6aad5afede14 32 fields · synced May 30, 2026
- EUDAMED d0835dbc-1e24-4201-921f-eccad0196853 61 fields · synced Jul 9, 2026