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Marqueur cornée diam 9 mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17520X10Model 17249X1
by Moria S.A.
Identity
- Trade Name
- Marqueur cornée diam 9 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 EUDAMED17520X10 EUDAMEDONE S- Corneal marker diameter 9mm X10 FDA UDI
Identifiers
- Catalog Number
- 17520X10 FDA UDI
- Primary DI / UDI-DI
- 03700483622733 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
Marqueur cornée diam 9 mm by Moria S.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 9a974557-ca28-4bd0-828f-d88d5367ab58 61 fields · synced Aug 3, 2026
- FDA UDI c46ff5a0-b5e2-4bc0-b4b4-37df314b93c8 33 fields · synced May 30, 2026