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Silicone Ear Tips
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8-68-31507Model 8-68-31514
Identity
- Trade Name
- Silicone Ear Tips EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- Silicone Ear tips EUDAMEDSilicone Eartip, 11 mm semi gray, mushroom FDA UDI
- Model / Reference
- 8-68-31514 EUDAMED8-68-31507 EUDAMED1012, Ear Tip Kit, 11mm 50 pcs FDA UDI
- Description
- Silicone Eartip, 11 mm semi gray, mushroom FDA UDI
Identifiers
- Catalog Number
- 8-68-31507 FDA UDI
- Primary DI / UDI-DI
- 05713315003561 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA001455K EUDAMED
- Direct Marketing DI
- 05713315003561 EUDAMED
- FDA Product Code
- ETY FDA UDIETT FDA UDI
- EMDN Code
- Z12149005 IMPEDANCE METERS FOR THE AUDITORY SYSTEM EUDAMED
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1090 FDA UDI874.1100 FDA UDI
- Market of Registration
- Denmark 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Impedance audiometer
Silicone Ear Tips by Natus Medical Denmark ApS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Impedance audiometer.
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- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
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- nanoTymp Set — PATH medical GmbH · Class II
- VIOLA — INVENTIS SRL · Class II
- GN Otometrics A/S — Natus Medical Denmark ApS · Class II
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 | 5713315NA001455K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED 485cfde7-dd6a-4afd-b2c8-04a176852d62 61 fields · synced Jul 20, 2026
- FDA UDI 040d78e8-9141-489e-b19c-dedee91819ef 34 fields · synced May 30, 2026