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Otoflex Accessory
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8-69-28000Model 8-67-41300
Identity
- Trade Name
- Otoflex Accessory EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- 1012 Otoflex Cavity Set EUDAMED
- Model / Reference
- 8-67-41300 EUDAMED8-69-28000 EUDAMED"Immittance Probe Tip Cleaning kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315001895 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00032DY EUDAMED
- Direct Marketing DI
- 05713315001895 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
- Not 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
No
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
Otoflex Accessory 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 | 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 d2d43e52-d72c-4e31-9000-550bbefc2804 61 fields · synced Jun 18, 2026
- FDA UDI 5a3d4f88-cb13-4f34-906a-79c087745ec3 34 fields · synced May 30, 2026