← Back to catalogue
1076 Aurical Otocam 300
EUDAMEDClass I (EU MDR)
Ref 8-62-42700Model OtocamRef 8-62-42710
Identity
- Device Name
- 1076 Aurical Otocam 300 EUDAMED
- Model / Reference
- Otocam EUDAMED8-62-42700 EUDAMED8-62-42710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315008573 EUDAMED05713315008580 EUDAMED
- Basic UDI-DI
- 5713315NA0003153 EUDAMED
- EMDN Code
- Z12021009 DIRECT OUTPATIENT VIDEO-OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
1076 Aurical Otocam 300 by Natus Medical Denmark ApS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5713315NA0003153 | Class I | Active |
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 c2161907-b496-40c2-b245-803fdea0579d 61 fields · synced Jul 31, 2026
- EUDAMED 69ca4bfe-0c99-41f7-907d-828fd03389ab 61 fields · synced May 17, 2026