Identity
- Trade Name
- Wire Speculum EUDAMED
- Device Name
- Disposable Ophthalmic speculum EUDAMED
- Model / Reference
- F4-H1-40-16（SO-15051-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044454840 EUDAMED
- Basic UDI-DI
- 697504445SPECULUMLH EUDAMED
- EMDN Code
- Q021107 OPHTHALMIC SURGERY RETRACTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Wire Speculum by Sihong Ophsurin Co., Ltd — Class IIa — 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 | 697504445SPECULUMLH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sihong Ophsurin Co., Ltd.
- EUDAMED SRN
- CN-MF-000037458
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED a787a2c1-be37-48d7-8f44-21789f509104 61 fields · synced Jun 14, 2026