Identity
- Trade Name
- Head, ML7, 100 Micron FDA UDI
- Generic Name
- Microkeratome FDA UDI
- Device Name
- ML7 Head; 100µm EUDAMED100 Micron Head for use with the ML7 Microkeratome FDA UDI
- Model / Reference
- 0100ML7 EUDAMEDFDA UDI
- Description
- 100 Micron Head for use with the ML7 Microkeratome FDA UDI
Identifiers
- Catalog Number
- 0100ML7 FDA UDI
- Primary DI / UDI-DI
- 00850724001827 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850724001827 EUDAMED
- FDA Product Code
- HNO FDA UDI
- EMDN Code
- Z1212020580 MICROKERATOMY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Microkeratome FDA UDI
- Models / Variants
- ML7 Head EUDAMEDFDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4370 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
ML7 Head - ML7 Head by Med Logics Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models — 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-00850724001827 | 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 aede9fe7-f78e-4f75-a0b9-8936839867e3 61 fields · synced Jul 31, 2026
- FDA UDI c29f41e1-c1f8-4cbc-9e27-319fcc116457 35 fields · synced May 30, 2026