E5 eyevan
Ref P1 48 BFST, SEYMOUR 48 OLB, SULLIVAN 50 PBK, M19 46 MBRWGWG, ZEN-E 57 SMK, DIM 52 TT, CASSADY 46 SMK, ALBEDO 47 RGR, ROBERT 46 DT, P10 48 SBWG, CALDWELL 47 OLB, ATLAS(46) 46 G, ACOSTA 46 OLB, FOREST 54 BRBGH, PUERTO(47) 47 ORS, DD-22T 47 LLT, M20 50 MBKMBK, LUBIN 48 OD, FOSTER 47 SMK, PHIL(44)-E 44 PBK, E-0505-(47) 47 SMKG, E-0508 47 ODG, P16(50)E 50 BC, LIVINGSTON(47)-E 47 CHGY, M3 47 MBKST, ATLAS(46) 46 AG-C, ATLAS(46) 46 G-C2, M23 52 DMSDMS, P12 53 BLST, M21 48 MBRWGWG, FOREST 54 S, P11 47 BKST, E-0512(43) 43 TORT2AG, ESCENAS 47 BG, WEBB(49) 49 SMK, BYRON(47) 47 ECR, SEYMOUR 48 SMK, ORBIT(44) 44 G-N LT.BLU, E-0504 48 BKG, LOEWY(45)-E 45 PBK, GRAIN 53 S, CRESTON 46 AG-C, BERMAN-E 46 ECR, BELL 46 SPA, LOEWY(45) 45 TRF, CONNER 46 TORT2, M7 47 MBRDM, MATHSSON 47 DBZ, LIVINGSTON(47)-E 47 OLB, M2 47 AGWG, DANNY-R 47 TORTModel Plastic/Combination, Q02100203, Plastic, Metal
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The E5 eyevan medical device is a metal and plastic spectacle frames without lenses, designed for implantation as an intraocular lens. It has been approved for use in the European Union and is marketed under the brand name EYEVAN Europe.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number457144502RXCMBE6 | Date3 Apr 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- E5 eyevanEyevan
- Device Name
- Metal spectacle frames without lensesC1 45 Bkwg
- Model / Reference
- Plastic/Combination, P1 48 BFST, Q02100203, SEYMOUR 48 OLB, Plastic, SULLIVAN 50 PBK, Metal, M19 46 MBRWGWG, ZEN-E 57 SMK, DIM 52 TT, CASSADY 46 SMK, ALBEDO 47 RGR, ROBERT 46 DT, P10 48 SBWG, CALDWELL 47 OLB, ATLAS(46) 46 G, ACOSTA 46 OLB, FOREST 54 BRBGH, PUERTO(47) 47 ORS, DD-22T 47 LLT, M20 50 MBKMBK, LUBIN 48 OD, FOSTER 47 SMK, PHIL(44)-E 44 PBK, E-0505-(47) 47 SMKG, E-0508 47 ODG, P16(50)E 50 BC, LIVINGSTON(47)-E 47 CHGY, M3 47 MBKST, ATLAS(46) 46 AG-C, ATLAS(46) 46 G-C2, M23 52 DMSDMS, P12 53 BLST, M21 48 MBRWGWG, FOREST 54 S, P11 47 BKST, E-0512(43) 43 TORT2AG, ESCENAS 47 BG, WEBB(49) 49 SMK, BYRON(47) 47 ECR, SEYMOUR 48 SMK, ORBIT(44) 44 G-N LT.BLU, E-0504 48 BKG, LOEWY(45)-E 45 PBK, GRAIN 53 S, CRESTON 46 AG-C, BERMAN-E 46 ECR, BELL 46 SPA, LOEWY(45) 45 TRF, CONNER 46 TORT2, M7 47 MBRDM, MATHSSON 47 DBZ, LIVINGSTON(47)-E 47 OLB, M2 47 AGWG, DANNY-R 47 TORT
- Primary DI / UDI-DI
- 04571445020237, 04582667971825, 04582667971016, 04582669047184, 04582669045883, 04582669012908, 04582667970873, 04582669011635, 04571445057509, 04582667990918, 04582667975632, 04582667985181, 04582667980926, 04582669046217, 04582669006129, 04582667975717, 04582669059101, 04582667972495, 04571445022637, 04582667990536, 04582667989691, 04582669005917, 04582669047313, 04582669058050, 04571445020107, 04582667985235, 04571445023153, 04582669059484, 04582667991021, 04582669059255, 04582669046248, 04582667990949, 04582669000356, 04571445056779, 04582667972778, 04582669001544, 04582667971849, 04582669008277, 04571445052375, 04582667990550, 04582669045043, 04582667993865, 04582669000752, 04582669000769, 04582667974406, 04582669001131, 04582667990765, 04582667975779, 04582669058036, 04571445020060, 04571445021678
- Basic UDI-DI
- 457144502RXCMBE6, 458266797RXCMBTJ, 458266797RXPLAVE, 458266904RXMTLRK, 458266904RXPLAQL, 458266901RXPLAPD, 457144505RXCMBFD, 458266799RXPLAW8, 458266798RXMTLWS, 458266798RXCMBTX, 458266900RXPLANY, 458266905RXMTLRY, 458266900RXCMBM4, 458266905RXPLAQZ, 457144502RXMTLGZ, 457144505RXMTLJ8, 458266900RXMTLPX, 458266799RXMTLX7, 458266797RXMTLWD
- EMDN Code
- Q02100203, Q02100202, Q02100201
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- JP-MF-000028437
- Authorised representative
- EYEVAN Europe FR-AR-000025678
Other devices from Eyevan Inc.
Properties
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