← Back to catalogue
Otoscope
EUDAMEDClass I (EU MDR)
Ref SW-OT16, SW-OT16J,SW-OT16N, SW-OT16S,SW-OT16L,SW-OT16R， SW-OT16F,SW-OT16C,SW-OT16LC， SW-OT03,SW-GP06,SW-OT11, SW-GP09BModel SW-OT16, SW-OT16J,SW-OT16N, SW-OT16S,SW-OT16L,SW-OT16R， SW-OT16F,SW-OT16C,SW-OT16LC， SW-OT03,SW-GP06,SW-OT11, SW-GP09B,SW-GP09C,SW-GP20
Identity
- Trade Name
- OTOSCOPE EUDAMED
- Device Name
- OTOSCOPE EUDAMED
- Model / Reference
- SW-OT16, SW-OT16J,SW-OT16N, SW-OT16S,SW-OT16L,SW-OT16R， SW-OT16F,SW-OT16C,SW-OT16LC， SW-OT03,SW-GP06,SW-OT11, SW-GP09B,SW-GP09C,SW-GP20 EUDAMEDSW-OT16, SW-OT16J,SW-OT16N, SW-OT16S,SW-OT16L,SW-OT16R， SW-OT16F,SW-OT16C,SW-OT16LC， SW-OT03,SW-GP06,SW-OT11, SW-GP09B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978724260076 EUDAMED
- Basic UDI-DI
- 697872426008PF EUDAMED
- Direct Marketing DI
- 06978724260076 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
Otoscope by Ruian Sunnyworld International Trade 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 | 697872426008PF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ruian Sunnyworld International Trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000028674
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED f363f22b-2a43-47e2-a504-c095636e5e77 61 fields · synced Oct 6, 2026
- EUDAMED f363f22b-2a43-47e2-a504-c095636e5e77-1 61 fields · synced Jun 10, 2026