Identity
- Trade Name
- OTOSCOPES EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 8300059319 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04035873071167 EUDAMED
- Basic UDI-DI
- 4035873120101029S EUDAMED
- Direct Marketing DI
- 04035873071167 EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT 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
Otoscopes by Henke-Sass, Wolf 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 | 4035873120101029S | Class I | Active |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
- EUDAMED SRN
- DE-MF-000005531
Sources (1)
- EUDAMED 5725ae9a-944e-4c88-b144-b10c5690e31c 61 fields · synced Jun 18, 2026