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Insert Earphone Tip 10mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 100898-100Model ET-IP10mm
Identity
- Trade Name
- Ear Tip IT-01 Pack/100 pcs. FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Insert Earphone Tip 10mm EUDAMEDInsert Earphone Tips FDA UDI
- Model / Reference
- ET-IP10mm EUDAMED100898-100 EUDAMEDFDA UDI
- Description
- Insert Earphone Tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143182 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022Earphones-17Q EUDAMED
- Unit of Use DI
- 04260223143168 EUDAMED
- 510(k) Number
- K133012 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDIETT FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 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
Insert Earphone Tip 10mm 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 | 0426022Earphones-17Q | 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 2b9331db-6498-4e8b-9695-f8c3672d5d66 61 fields · synced Aug 4, 2026
- FDA UDI f62b17ac-9ee6-48d0-b528-f567f41236ea 34 fields · synced May 26, 2026