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ComfyArt Silicone Hydrogel One Day Soft Contact Lenses
EUDAMEDClass IIa (EU MDR)
Ref CA01D001Model Rule 5
Identity
- Trade Name
- ComfyArt Silicone Hydrogel One Day Soft Contact Lenses EUDAMED
- Device Name
- Soft contact lens EUDAMED
- Model / Reference
- Rule 5 EUDAMEDCA01D001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 4719878900001BB EUDAMED
- Basic UDI-DI
- 471987890CA01D001G3 EUDAMED
- EMDN Code
- Q02100499 CONTACT LENSES - OTHER 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
ComfyArt Silicone Hydrogel One Day Soft Contact Lenses 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 | 471987890CA01D001G3 | 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 063c6021-c5ac-40fb-9ec8-fbfc51e59962 61 fields · synced Jun 17, 2026