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Thornton-Optical Zone Markers
EUDAMEDClass I (EU MDR)
Ref RR5-A125-H4(TM-20003-1)
Identity
- Trade Name
- Thornton-Optical Zone Markers EUDAMED
- Device Name
- Reusable Ophthalmic Marker EUDAMED
- Model / Reference
- RR5-A125-H4(TM-20003-1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044458343 EUDAMED
- Basic UDI-DI
- 697504445RMARKER3H EUDAMED
- EMDN Code
- L179001 OPHTHALMOLOGY SURGICAL GAUGES, REUSABLE 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
Category: Ophthalmic calliper
Thornton-Optical Zone Markers by Sihong Ophsurin Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 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 3b1d3cf9-49c0-497b-9e97-4ad503556e92 61 fields · synced Jul 8, 2026