Identity
- Trade Name
- CLB® EUDAMEDML7061 (Minus 30) FDA UDI
- Generic Name
- Keratome blade, single-use FDA UDI
- Device Name
- Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head FDA UDI
- Model / Reference
- ML7061 (-30) EUDAMEDFDA UDI
- Description
- Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head FDA UDI
Identifiers
- Catalog Number
- ML7061 (-30) FDA UDI
- Primary DI / UDI-DI
- 10850724001169 EUDAMED00850724001162 FDA UDI
- Basic UDI-DI
- B-10850724001169 EUDAMED
- 510(k) Number
- K020079 FDA UDI
- FDA Product Code
- HNO FDA UDI
- EMDN Code
- Z1212020585 MICROKERATOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Keratome blade, single-use FDA 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Corneal punch set
Clb® by Med Logics Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-10850724001169 | 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 85c005b5-b325-4224-828d-a12567a0baea 61 fields · synced Jul 13, 2026
- FDA UDI ee42a24b-cdef-4dc0-ba76-dd2c134434ab 36 fields · synced May 25, 2026