Identity
- Trade Name
- OX2 EUDAMEDOtoskop OX2 EUDAMED
- Device Name
- Otoskop OX2 EUDAMED
- Model / Reference
- OX2 EUDAMEDM-304-00000-4000 EUDAMEDOtoskop OX2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260499410223 EUDAMED04260499410131 EUDAMED
- Basic UDI-DI
- 426049941OTOLL EUDAMED
- Direct Marketing DI
- 04260499410223 EUDAMED04260499410131 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
Ox2 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 (2)
- EUDAMED fc3cc18a-04eb-416f-8730-30349ed420fc 61 fields · synced Jul 27, 2026
- EUDAMED 48e9b280-75aa-455c-867a-08f4409e12ab 61 fields · synced May 18, 2026