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Marqueur cornée diam 8 mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17518X5Model 17249X1
by Moria S.A.
Identity
- Trade Name
- Marqueur cornée diam 8 mm EUDAMEDONE FDA UDI
- Generic Name
- Corneal marker, single-use FDA UDI
- Device Name
- Toric IOL pre-op marker, bubble level EUDAMED
- Model / Reference
- 17249X1 EUDAMED17518X5 EUDAMEDONE S- Corneal marker diameter 8mm X5 FDA UDI
Identifiers
- Catalog Number
- 17518X5 FDA UDI
- Primary DI / UDI-DI
- 03700483612314 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Markers3BX EUDAMED
- FDA Product Code
- HMR FDA UDI
- EMDN Code
- Q020203 CORNEAL MARKERS EUDAMED
- GMDN Term
- Corneal marker, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4570 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Corneal marker, reusable
Marqueur cornée diam 8 mm by Moria S.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37004836Markers3BX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Moria S.A.
- EUDAMED SRN
- FR-MF-000000336
Sources (2)
- EUDAMED 1dbf8269-faca-40d2-a169-215f90b3480f 61 fields · synced Jul 13, 2026
- FDA UDI 031f120f-750e-47d9-8f71-bfb689a21974 33 fields · synced May 30, 2026