Identity
- Trade Name
- ML Eyespear FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- CleanTouch PVA Eye Spears EUDAMEDOphthalmic Sponge. The CleanTouch PVA Eye Spears are sterile, single-use devices designed to absorb excess fluids on the human eye. FDA UDI
- Model / Reference
- ML100 EUDAMEDML 100 FDA UDI
- Description
- Ophthalmic Sponge. The CleanTouch PVA Eye Spears are sterile, single-use devices designed to absorb excess fluids on the human eye. FDA UDI
Identifiers
- Catalog Number
- ML 100 FDA UDI
- Primary DI / UDI-DI
- 40850724001504 EUDAMEDFDA UDI
- Basic UDI-DI
- B-40850724001504 EUDAMED
- 510(k) Number
- K002279 FDA UDI
- FDA Product Code
- HOZ FDA UDI
- EMDN Code
- Q020503 RETINAL SPONGES EUDAMED
- GMDN Term
- Ophthalmic sponge FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4790 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
Radiation Sterilization FDA UDI
CleanTouch PVA Eye Spears by Med Logics Inc — 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-40850724001504 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 a142541a-066c-4f05-89b7-9fd272a5a62d 61 fields · synced Jul 15, 2026
- FDA UDI 5b139dec-fa12-484f-a3f0-c6d523d84113 36 fields · synced May 30, 2026