Identity
- Trade Name
- Capsulorhexis Forceps EUDAMED
- Device Name
- Disposable Ophthalmic Forceps EUDAMED
- Model / Reference
- R-C105-T4H0N（SF-11223-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044450187 EUDAMED
- Basic UDI-DI
- 697504445SVFORCEPQU EUDAMED
- EMDN Code
- Q021102 OPHTHALMIC SURGERY FORCEPS, 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
Capsulorhexis Forceps 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 | 697504445SVFORCEPQU | 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 bfcf4d94-b929-4c89-a8ad-aae9ed4b7800 61 fields · synced Jul 16, 2026