Tecnis Eyhance IOL with Tecnis Simplicity Delivery System
by Johnson & Johnson Surgical Vision, Inc. EUDAMED
Active
Ref DIB00I0205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5050474a000239C | Date6 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2252965TD02 Restricted
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 16 Jul 2025
- Expires
- 1 Oct 2028
- Reason
- Other
- 2252965CE02 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 16 Jul 2025
- Expires
- 1 Mar 2027
- Reason
- Other
Specification
- Device Name
- Tecnis Eyhance Monofocal Simplicity Preloaded IOL
- Model / Reference
- DIB00I0205
- Primary DI / UDI-DI
- 05050474655416
- Basic UDI-DI
- 5050474a000239C
- EMDN Code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
- Device Class
- Class IIb
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000038968
- Authorised representative
- AMO Ireland IE-AR-000013513
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Properties
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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