Identity
- Trade Name
- Bores Axis Marker EUDAMED
- Device Name
- Reusable Ophthalmic Marker EUDAMED
- Model / Reference
- RR5-A110-H9(TM-34022-2) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044458350 EUDAMED
- Basic UDI-DI
- 697504445RMARKER3H EUDAMED
- EMDN Code
- L179001 OPHTHALMOLOGY SURGICAL GAUGES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa 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
Bores Axis Marker 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 | 697504445RMARKER3H | 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 79daf238-bc66-4854-81f9-84300e6352b1 61 fields · synced Jul 9, 2026