Identity
- Trade Name
- Bausch + Lomb ULTRA ONE DAY Multifocal EUDAMED
- Device Name
- Soft Corrective Contact Lens, Daily-Disposable (Kalifilcon A) EUDAMED
- Model / Reference
- Many EUDAMED
Identifiers
- Primary DI / UDI-DI
- 0196527M0022GL EUDAMED
- Basic UDI-DI
- 0310119B0020YV 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
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
Bausch + Lomb ULTRA ONE DAY Multifocal 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 | 0310119B0020YV | 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 33307f52-3063-4e65-bb59-17aa4e330874 61 fields · synced Jul 10, 2026