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Ophthalmoscope
EUDAMEDClass I (EU MDR)
Ref SW-OT15,SW-OT15S,SW-OT15R， SW-OT15F,SW-OT15C,SW-OT15LC Model SW-OT15,SW-OT15S,SW-OT15R， SW-OT15F,SW-OT15C,SW-OT15LC
Identity
- Trade Name
- OPHTHALMOSCOPE EUDAMED
- Device Name
- OPHTHALMOSCOPE EUDAMED
- Model / Reference
- SW-OT15,SW-OT15S,SW-OT15R， SW-OT15F,SW-OT15C,SW-OT15LC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978724260083 EUDAMED
- Basic UDI-DI
- 697872426009PH EUDAMED
- Direct Marketing DI
- 06978724260083 EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES 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
Ophthalmoscope 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 | 697872426009PH | Class I | Active |
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Manufacturer
- Manufacturer
- Ruian Sunnyworld International Trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000028674
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 11761f40-170b-4c74-b1aa-8d3a7e27d57f 61 fields · synced Oct 6, 2026
- EUDAMED 11761f40-170b-4c74-b1aa-8d3a7e27d57f-1 61 fields · synced Jun 10, 2026