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1076 Aurical Otocam 300
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8-35-30800Model Otocam
Identity
- Trade Name
- GN Otometrics A/S FDA UDI
- Generic Name
- Auditory canal scanner FDA UDI
- Device Name
- 1076 Aurical Otocam 300 EUDAMED
- Model / Reference
- Otocam EUDAMED8-35-30800 EUDAMEDDesktop Cradle FDA UDI
Identifiers
- Catalog Number
- 8-35-30800 FDA UDI
- Primary DI / UDI-DI
- 05713315000089 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA0003153 EUDAMED
- FDA Product Code
- ERA FDA UDI
- EMDN Code
- Z12021009 DIRECT OUTPATIENT VIDEO-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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
1076 Aurical Otocam 300 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 | 5713315NA0003153 | 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 c3a73f90-afd8-48c6-9057-db4a2b5fb922 61 fields · synced Jun 18, 2026
- FDA UDI 97d3b544-f880-44a1-8441-6d85d421627c 33 fields · synced May 30, 2026