Identity
- Trade Name
- ATMOS Video Otoskop EUDAMED
- Device Name
- Otoskop OX2 EUDAMED
- Model / Reference
- OX2 EUDAMEDATMOS Video Otoskop EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260499410056 EUDAMED
- Basic UDI-DI
- 426049941OTOLL EUDAMED
- Direct Marketing DI
- 04260499410056 EUDAMED
- EMDN Code
- Z12021009 DIRECT OUTPATIENT VIDEO-OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
ATMOS Video Otoskop by orlvision GmbH — 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 | 426049941OTOLL | Class I | Active |
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Manufacturer
- Manufacturer
- Orlvision GmbH
- EUDAMED SRN
- DE-MF-000013894
Sources (1)
- EUDAMED cb6ce026-1a38-4133-b924-206af1c28cf8 61 fields · synced Oct 6, 2026