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Marqueur de Bores 12mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 20215X1
by Moria S.A.
Identity
- Trade Name
- Marqueur de Bores 12mm EUDAMEDMORIA FDA UDI
- Generic Name
- Corneal marker, reusable FDA UDI
- Device Name
- Marqueur de Bores 12mm EUDAMED
- Model / Reference
- 20215X1 EUDAMEDBores marker 12mm FDA UDI
Identifiers
- Catalog Number
- 20215X1 FDA UDI
- Primary DI / UDI-DI
- 03700483609635 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700483609635 EUDAMED
- FDA Product Code
- HMR FDA UDI
- EMDN Code
- L1799 OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER EUDAMED
- GMDN Term
- Corneal marker, reusable 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Marqueur de Bores 12mm by Moria S.A. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03700483609635 | 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 976565ef-8b40-4ce1-881b-22dbb4e515cc 61 fields · synced Jul 19, 2026
- FDA UDI ee225f9e-f9fc-4314-92ef-133e13d65b01 33 fields · synced May 30, 2026