Identity
- Device Name
- CleanTouch PVA Eye Spears - Bulk EUDAMED
- Model / Reference
- ML100B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50850724001501 EUDAMED
- Basic UDI-DI
- B-50850724001501 EUDAMED
- EMDN Code
- Q020503 RETINAL SPONGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
CleanTouch PVA Eye Spears - Bulk by Med Logics Inc — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-50850724001501 | Class I | Active |
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Manufacturer
- Manufacturer
- Med-Logics, Inc.
- EUDAMED SRN
- US-MF-000004600
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 37cc598c-c60d-403d-8c2a-6058dbf03bcf 61 fields · synced Jun 18, 2026