Identity
- Trade Name
- ML7 Eye Marker FDA UDI
- Generic Name
- Eyeball fixation instrument, reusable FDA UDI
- Device Name
- Titanium Eye Marker EUDAMEDEye Marker use to mark the cornea to orientate the ML7 Vacuum Ring FDA UDI
- Model / Reference
- 2100ML7 EUDAMEDFDA UDI
- Description
- Eye Marker use to mark the cornea to orientate the ML7 Vacuum Ring FDA UDI
Identifiers
- Catalog Number
- 2100ML7 FDA UDI
- Primary DI / UDI-DI
- 00850724001902 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850724001902 EUDAMED
- FDA Product Code
- HMR FDA UDI
- EMDN Code
- Z1212020580 MICROKERATOMY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Eyeball fixation instrument, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4570 FDA UDI
- Market of Registration
- Ireland 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
Titanium Eye Marker by Med Logics Inc — Class IIa — 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-00850724001902 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Med-Logics, Inc.
- EUDAMED SRN
- US-MF-000004600
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 121ee25a-1706-4854-a087-f04d88e3bb33 61 fields · synced Jun 20, 2026
- FDA UDI e2d5fe19-35db-497f-8c56-978e1c2a8473 35 fields · synced May 30, 2026