Identity
- Trade Name
- Otoflex Accesory EUDAMEDMadsen FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- 1012 Otoflex Cavity Set EUDAMEDCavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100 FDA UDI
- Model / Reference
- 8-67-41300 EUDAMED1012 OTOflex Cavity set FDA UDI
- Description
- Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100 FDA UDI
Identifiers
- Catalog Number
- 8-67-41300 FDA UDI
- Primary DI / UDI-DI
- 05713315009013 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00032DY EUDAMED
- Direct Marketing DI
- 05713315009013 EUDAMED
- 510(k) Number
- K033645 FDA UDI
- FDA Product Code
- ETY 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 UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Otoflex Accesory by Natus Medical Denmark ApS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Impedance audiometer.
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- 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 | 038283NA00032DY | 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 2ac8809b-b711-4c61-8f15-b7d8e25f0227 61 fields · synced Jun 18, 2026
- FDA UDI d15987c0-c800-4b74-9688-f6d278fa38f1 35 fields · synced May 30, 2026