Identity
- Trade Name
- Foam Ear Tips EUDAMEDFoam Eartip, 3B (Small) FDA UDI
- Generic Name
- Audiometric ear tip FDA UDI
- Device Name
- Foam Eartip EUDAMED
- Model / Reference
- 80A4821000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 80A4821000 FDA UDI
- Primary DI / UDI-DI
- 05713315009310 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA001075B EUDAMED
- FDA Product Code
- ETT FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Audiometric ear tip FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.1100 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Foam Ear Tips by Natus Medical Denmark ApS — 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 | 5713315NA001075B | 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 d4fcb237-0fb2-4ba9-b717-6818f479a95c 61 fields · synced Jun 18, 2026
- FDA UDI 1beb1972-24d0-45b2-a3ec-8473003e8d16 33 fields · synced May 30, 2026