EyeCee ONE preloaded
Part of a family of 40 devices: see the family page
Ref EyeCee ONE preloadedModel NP-1
EyeCee ONE preloaded is a Class IIb device made by Nidek Co., Ltd., registered in EUDAMED on 21 Mar 2024 (Basic UDI-DI 4987669227GL) with CE/MDR certificate 4202074CE04 valid until 1 Nov 2026, expired as of 25 Oct 2026.
Active
CE MDR
Valid until
13 Dec 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4202074CE04 | Date30 Oct 2025 | StatusExpired |
Official records
- EUDAMED public site 4987669227GL
Certificates
- 4202074TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 30 Oct 2025
- Expires
- 13 Dec 2028
- Reason
- Add device or group
- 4202074CE04 Expired
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 30 Oct 2025
- Expires
- 1 Nov 2026
- Reason
- Other
Timeline
- Registered EUDAMED 4987669227GL
- Certificate issued EUDAMED 4202074CE04
- Certificate issued EUDAMED 4202074TD01
- Certificate expired EUDAMED 4202074CE04
- Certificate expires EUDAMED 4202074TD01
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- NP-1, EyeCee ONE preloaded
- Primary DI / UDI-DI
- 04987669316146
- Basic UDI-DI
- 4987669227GL
- EMDN code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- JP-MF-000040151
- Authorised representative
- NIDEK SA FR-AR-000000341
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