← Back to catalogue
Clb®
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ML7070 (+10)Ref ML7071 (0)Ref ML7071 (+10)Ref ML7071 (-20)
Identity
- Trade Name
- CLB® EUDAMEDML7070 (Plus 10) FDA UDI
- Generic Name
- Keratome blade, single-use FDA UDI
- Device Name
- Sterile disposables microkeratome blade, for use on the Hansatome Microkeratome FDA UDI
- Model / Reference
- ML7070 (+10) EUDAMEDFDA UDIML7071 (0) EUDAMEDML7071 (+10) EUDAMEDML7071 (-20) EUDAMED
- Description
- Sterile disposables microkeratome blade, for use on the Hansatome Microkeratome FDA UDI
Identifiers
- Catalog Number
- ML7070 (+10) FDA UDI
- Primary DI / UDI-DI
- 10850724001596 EUDAMED10850724001640 EUDAMED10850724001657 EUDAMED10850724001626 EUDAMED00850724001599 FDA UDI
- Basic UDI-DI
- B-10850724001596 EUDAMEDB-10850724001640 EUDAMEDB-10850724001657 EUDAMEDB-10850724001626 EUDAMED
- 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
Similar devices
Also classified as Corneal punch set.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Tête CBSU 50 pour Chambre Artificielle — Moria S.A. · Class IIa
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- set one use plus (130/-1) — Moria S.A. · Class IIa
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Corneal Trephine — Katena Products, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
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-10850724001596 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Med-Logics, Inc.
- EUDAMED SRN
- US-MF-000004600
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (5)
- EUDAMED fcb228e4-4367-4b3d-b0cd-6f4d60d6b964 61 fields · synced Jul 14, 2026
- EUDAMED fd06439a-1a5f-4cfd-b4f8-bcaec428ad11 61 fields · synced May 16, 2026
- EUDAMED 86fd5ff9-199c-426e-ba52-189e823a4ef8 61 fields · synced May 17, 2026
- EUDAMED 69973a98-36d4-4b90-bf27-e28f1f3747e4 61 fields · synced May 17, 2026
- FDA UDI e05ff5cc-8482-4403-8954-f43578d827ab 35 fields · synced May 30, 2026