Soft-Xpr
by Lentilles France EUDAMED
Ref MANYModel STERILE SOFT CONTACT LENS EMDN Q0210040102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFR26/0000004 | Date11 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Model / Reference
- STERILE SOFT CONTACT LENS, MANY
- Primary DI / UDI-DI
- 13664043000409, 13664043000393, 13664043000348, 13664043000362, 13664043000355, 13664043000331, 13664043000416, 13664043000423
- Basic UDI-DI
- 36640434BC
- EMDN Code
- Q0210040102 Contact lenses - hydrogel, reusable
- Device Class
- Class IIa
- Special Device Type
- Made to order soft 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 (12)
- 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 (8)
- EUDAMED 1f978f10-ce67-41d4-9ec1-6c4ae05c650f
- EUDAMED 13664043000393|36640434BC
- EUDAMED 13664043000348|36640434BC
- EUDAMED 13664043000362|36640434BC
- EUDAMED 13664043000355|36640434BC
- EUDAMED 13664043000331|36640434BC
- EUDAMED 13664043000416|36640434BC
- EUDAMED 13664043000423|36640434BC