Identity
- Trade Name
- Sliding Speculum EUDAMED
- Device Name
- Reusable Ophthalmic Speculum EUDAMED
- Model / Reference
- RT2-H10-53-15（TO-35002-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044458299 EUDAMED
- Basic UDI-DI
- 697504445RSPECULUMBM EUDAMED
- EMDN Code
- L170102 OCULAR AND ENDOCULAR RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Sliding 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 | 697504445RSPECULUMBM | 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 (2)
- EUDAMED 909d65b9-9296-4a84-85c7-059379cedc18 61 fields · synced Aug 1, 2026
- EUDAMED cb5de636-3169-472f-9ee6-7d10c65d045f 61 fields · synced Aug 1, 2026