Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe CNAET0
by Alcon Laboratories, Inc. 39 variants
Ref CNAET0.125
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038065GMN000246HD 00380652406154 | Date3 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00380652406154 | Date4 Mar 2025 | StatusListed |
Certificates
- G70 020895 0414 Withdrawn
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 11 Jun 2026
- Expires
- 20 Jan 2030
- Reason
- Transferred to other nb
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Clareon Vivity, AutonoMe EUDAMEDClareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe GUDID
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic
- Device Name
- Clareon Vivity Extended Vision Hydrophobic IOL with the AutonoMe Automated Preloaded Delivery System
- Model / Ref / Catalog
- CNAET0.125, CNAET0
- Primary DI / UDI-DI
- 00380652406154
- Basic UDI-DI
- 038065GMN000246HD
- FDA Product Code
- POE
- EMDN Code
- P030102100201 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic
- Device Class
- Class IIb EUDAMEDClass III GUDID
- Regulation Number
- 886.3600
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | CNAET0.125 | CNAET0 |
| Device Class | Class IIb | Class III |
Other devices from Alcon Laboratories, Inc.
Properties
Other properties (16)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No