Aks-Xpr
by Lentilles France EUDAMED
Ref MANYModel NON-STERILE SCLERAL CONTACT LENS
EMDN Q02100402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFR26/0000004 | Date11 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- FR26/0000004 Amended
Quality assurance EU MDR
- Notified body
- Notified body 1639
- Issued
- 11 May 2026
- Expires
- 13 Jan 2031
- Reason
- Mnf ar change
Specification
- Trade Name
- Aks-XprAks
- Model / Reference
- NON-STERILE SCLERAL CONTACT LENS, MANY
- Primary DI / UDI-DI
- 13664043000850, 13664043000805, 13664043000843, 13664043000829
- Basic UDI-DI
- 36640433BA
- EMDN Code
- Q02100402 Contact lenses - non hydrogel
- Device Class
- Class IIa
- Special Device Type
- Made to order Rigid Gas Permeable (RGP) contact lenses
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000006721
Other devices from Lentilles
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (4)
- EUDAMED bf77699e-a86a-403d-9ed8-551c006a157f
- EUDAMED 13664043000805|36640433BA
- EUDAMED 13664043000843|36640433BA
- EUDAMED 13664043000829|36640433BA