Identity
- Trade Name
- Apexlens co.,ltd EUDAMED
- Device Name
- Soft contact lenses EUDAMED
- Model / Reference
- Rule 5 EUDAMEDmany EUDAMED
Identifiers
- Primary DI / UDI-DI
- 4719878931014001111YY EUDAMED
- Basic UDI-DI
- 4719878902CA01D001GP EUDAMED
- EMDN Code
- X01010101 CONTACT LENSES WITHOUT AN INTENDED MEDICAL PURPOSE – HYDROGEL, DAILY SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Standard soft contact lenses EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Apexlens co., ltd by Apexlens Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4719878902CA01D001GP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apexlens Co., Ltd.
- EUDAMED SRN
- TW-MF-000033496
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 3a71a7d1-dddd-49e6-a845-8d47eacfc7af 61 fields · synced Jun 18, 2026