Identity
- Trade Name
- Otoscope EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- HS-OT10G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970384250008 EUDAMED
- Basic UDI-DI
- 697038425OTSTV 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
Otoscope by HONSUN (NANTONG) Co., Ltd. — 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 | 697038425OTSTV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009428
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED afe090a7-06a8-4b62-899d-64acf008a143 61 fields · synced Jun 18, 2026