Identity
- Trade Name
- GN Otometrics A/S FDA UDI
- Generic Name
- Auditory canal scanner FDA UDI
- Device Name
- 1093 OTOSCAN EUDAMED
- Model / Reference
- OTOSCAN EUDAMED8-61-20200 EUDAMED1093, Headset HS3 FDA UDI
Identifiers
- Catalog Number
- 8-61-20200 FDA UDI
- Primary DI / UDI-DI
- 05713315006005 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA000805G EUDAMED
- FDA Product Code
- ERA FDA UDI
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
- GMDN Term
- Auditory canal scanner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4770 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
1093 Otoscan 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 | 5713315NA000805G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED a7800448-efca-48b7-96ef-b6c0f7b5d675 61 fields · synced Jun 19, 2026
- FDA UDI 66917e51-43ea-4f99-829c-0e0cf263689b 33 fields · synced May 30, 2026