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Marqueur de Bores, 12 mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17251X10Model 17249X1
by Moria S.A.
Identity
- Trade Name
- Marqueur de Bores, 12 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 EUDAMED17251X10 EUDAMEDONE-BORES MARKER, 12MM FDA UDI
Identifiers
- Catalog Number
- 17251X10 FDA UDI
- Primary DI / UDI-DI
- 03700483611195 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Markers3BX EUDAMED
- FDA Product Code
- HMR FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER 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 de Bores, 12 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 5dde62a8-de55-42bb-8eeb-313c999ac3eb 61 fields · synced Jun 19, 2026
- FDA UDI 536c9482-e362-4913-a303-c5956811c7af 33 fields · synced May 30, 2026