Identity
- Trade Name
- SofLens daily disposable EUDAMED
- Device Name
- Soft Corrective Contact Lens, Daily-Disposable and Daily Wear (hilafilcon B) EUDAMED
- Model / Reference
- Many EUDAMED
Identifiers
- Primary DI / UDI-DI
- 0196527M0009GU EUDAMED
- Basic UDI-DI
- 0310119B0016Z6 EUDAMED
- EMDN Code
- Q021004010101 CONTACT LENSES - HYDROGEL, DAILY SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Standard soft contact lenses EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
SofLens daily disposable by Bausch & Lomb Incorporated — 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 | 0310119B0016Z6 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
- EUDAMED SRN
- US-MF-000001029
- Authorised Representative
- Bausch & Lomb Incorporated IE-AR-000000094
Sources (1)
- EUDAMED a406c10d-1eea-4d47-863f-bda0609fa68e 61 fields · synced Jul 16, 2026