Identity
- Device Name
- Sterile Soft Contact lenses EUDAMED
- Model / Reference
- IFU-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-880921805PTCLND EUDAMED
- Basic UDI-DI
- B-880921805PTCLND EUDAMED
- EMDN Code
- Q0210040102 CONTACT LENSES - HYDROGEL, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Sterile Soft Contact lenses by POLYTOUCH Co., Ltd. — Class IIa — 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-880921805PTCLND | Class IIa | Active |
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Manufacturer
- Manufacturer
- POLYTOUCH Co., Ltd.
- EUDAMED SRN
- KR-MF-000021514
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 029be46b-6d9c-4c54-89e0-e7ca8097b8ea 61 fields · synced Jul 13, 2026