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1047, Headstrap Comp
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8-69-38800Model 1-25-13600
Identity
- Trade Name
- 1047, HEADSTRAP COMP EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Electronystagmograph FDA UDI
- Device Name
- 1047 Face Cushion EUDAMED
- Model / Reference
- 1-25-13600 EUDAMED8-69-38800 EUDAMED1047, HEADSTRAP COMP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315004940 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA0003357 EUDAMED
- 510(k) Number
- K122550 FDA UDI
- FDA Product Code
- GWN FDA UDI
- EMDN Code
- Z12120124 VIDEO/ELECTRONYSTAGMOGRAPHS EUDAMED
- GMDN Term
- Electronystagmograph 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
No
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
1047, Headstrap Comp 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 | 5713315NA0003357 | 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 37dc0d86-3d23-491a-9b6a-4bfe4b52ff09 61 fields · synced Aug 2, 2026
- FDA UDI 55c69957-f76b-484e-8a20-87136d114769 33 fields · synced May 30, 2026