Identity
- Trade Name
- Castroviejo Caliper EUDAMED
- Device Name
- Reusable Ophthalmic Marker EUDAMED
- Model / Reference
- RS3-T86-H2P(TM-20005-1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044454314 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
Castroviejo Caliper by Sihong Ophsurin Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic calliper.
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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 fc35e310-6794-4a28-a32f-6dc03f813a9e 61 fields · synced Jul 8, 2026