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Otoscopes
EUDAMEDClass I (EU MDR)
Ref 89550240Ref 89550239Ref 8300058413Ref 8300059919Ref 8300055074Ref 8300059042Ref 89550242Ref 8300062478Ref 8300055081
Identity
- Trade Name
- OTOSCOPES EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 89550240 EUDAMED89550239 EUDAMED8300058413 EUDAMED8300059919 EUDAMED8300055074 EUDAMED8300059042 EUDAMED89550242 EUDAMED8300062478 EUDAMED8300055081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04035873011422 EUDAMED04035873063803 EUDAMED04035873070726 EUDAMED04035873071921 EUDAMED04035873076414 EUDAMED04035873070993 EUDAMED04035873063827 EUDAMED04035873072973 EUDAMED04035873076421 EUDAMED
- Basic UDI-DI
- 4035873120101029S EUDAMED
- Direct Marketing DI
- 04035873011422 EUDAMED04035873063803 EUDAMED04035873070726 EUDAMED04035873071921 EUDAMED04035873076414 EUDAMED04035873070993 EUDAMED04035873063827 EUDAMED04035873072973 EUDAMED04035873076421 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 (9)
- EUDAMED 9bcf8478-99f9-4271-9b33-63357092da51 61 fields · synced Oct 6, 2026
- EUDAMED 3a831031-d864-41fa-bbc5-e35a68e20f81 61 fields · synced May 17, 2026
- EUDAMED 9171189e-0c1b-47ba-a0f3-40bf7477c307 61 fields · synced May 17, 2026
- EUDAMED bf7ca30e-2961-4f51-9e88-92ab22bc2971 61 fields · synced May 17, 2026
- EUDAMED 2a4f10df-05b0-47f1-a3eb-41ba4087ebc3 61 fields · synced May 18, 2026
- EUDAMED 1b6a0c1e-52ba-4d12-bc8f-8023a8370248 61 fields · synced May 18, 2026
- EUDAMED e421fdb7-e912-4c37-8b9b-b107f9678b66 61 fields · synced May 19, 2026
- EUDAMED c8ed91e7-5df3-483c-9d7f-1e190f4d777c 61 fields · synced May 19, 2026
- EUDAMED 3b21fe9c-8d95-4d9a-8389-72256e40a14f 61 fields · synced May 19, 2026