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Disposable Snap Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8-64-21601Model Disposable Snap Electrodes
Identity
- Trade Name
- GN Otometrics A/S FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- Disposable Snap Electrodes EUDAMED
- Model / Reference
- Disposable Snap Electrodes EUDAMED8-64-21601 EUDAMEDDisposable Electrode 24" Wired Qty 10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315002649 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA0003459 EUDAMED
- 510(k) Number
- K061791 FDA UDI
- FDA Product Code
- GWN FDA UDI
- EMDN Code
- Z12140385 EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Auditory stimulator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1460 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
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
Disposable Snap Electrodes 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 | 5713315NA0003459 | 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 20b114bf-3797-45e7-a24a-8662e85fe0e5 61 fields · synced Jul 17, 2026
- FDA UDI 48033649-82da-41ee-8c7f-ab7f1cb20452 33 fields · synced May 30, 2026