Identity
- Trade Name
- Diamond Knives Handle EUDAMED
- Device Name
- Reusable ophthalmic Scalpel Handle EUDAMED
- Model / Reference
- RR11-S135-H4（TB-10002-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044458190 EUDAMED
- Basic UDI-DI
- 697504445RHANDLEX9 EUDAMED
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
Classification
- Device Class
- Class 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
Diamond Knives Handle by Sihong Ophsurin 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 | 697504445RHANDLEX9 | Class I | 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 3bbeb79c-a994-4982-9fdc-4f88762ca9db 61 fields · synced Jun 14, 2026