Identity
- Trade Name
- Bausch + Lomb ULTRA for Presbyopia EUDAMED
- Device Name
- Visibility Tinted Soft Corrective Contact Lenses, Daily Wear and Extended Wear (samfilcon A) EUDAMED
- Model / Reference
- Many EUDAMED
Identifiers
- Primary DI / UDI-DI
- 0196527M0006GN EUDAMED
- Basic UDI-DI
- 0310119B0018ZA EUDAMED
- EMDN Code
- Q0210040102 CONTACT LENSES - HYDROGEL, REUSABLE 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
Bausch + Lomb ULTRA for Presbyopia 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 | 0310119B0018ZA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
- EUDAMED SRN
- US-MF-000001029
- Authorised Representative
- Bausch & Lomb Incorporated IE-AR-000000094
Sources (1)
- EUDAMED 3f4d4099-8e05-4419-9edb-5bdb28109a4d 61 fields · synced Jun 19, 2026