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Ear Tip PM014H Pack/100 pcs.
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 100769-PH-100Ref 100772-PH-100Ref 100771-PH-100
Identity
- Trade Name
- PM011H EUDAMEDPM014H EUDAMEDPM013H EUDAMEDEar Tip PM014H Pack/100 pcs. FDA UDIEar Tip PM013H Pack/100 pcs. FDA UDIEar Tip PM011H Pack/100 pcs. FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Ear Tips for Ear Probes EUDAMED14 mm mushroom ear tip, hard version FDA UDI13 mm mushroom ear tip, hard version FDA UDI11 mm mushroom ear tip, hard version FDA UDI
- Model / Reference
- 100772-PH-100 EUDAMEDFDA UDI100771-PH-100 EUDAMEDFDA UDI100769-PH-100 EUDAMEDFDA UDI
- Description
- 14 mm mushroom ear tip, hard version FDA UDI13 mm mushroom ear tip, hard version FDA UDI11 mm mushroom ear tip, hard version FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223146909 EUDAMEDFDA UDI04260223146893 EUDAMEDFDA UDI04260223146879 EUDAMEDFDA 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 PM014H 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 (6)
- FDA UDI 2263521c-940f-43fa-894c-12649ad19d20 33 fields · synced Jul 31, 2026
- FDA UDI 9d4b578c-9248-41fd-b6f6-4d112f40c8b9 33 fields · synced May 30, 2026
- FDA UDI d2399ea9-4fce-4034-9fa0-93e3efba3ace 33 fields · synced May 30, 2026
- EUDAMED c9b0ce86-c4a7-404a-8d4b-d4a8e5076216 61 fields · synced Jul 10, 2026
- EUDAMED 00ad1b87-d3aa-43d6-9b99-67160f8a6f38 61 fields · synced Jul 30, 2026
- EUDAMED a9949e97-da83-46a2-9b0a-599b21d9180b 61 fields · synced Jul 31, 2026