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REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref B01E009Model OPD-Scan III
Identity
- Trade Name
- REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III EUDAMEDREFRACTIVE POWER / CORNEAL ANALYZER FDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refractive error, corneal curvature, shape of the anterior corneal surface (topography), and pupil size of the patient’s eye, and analyzes wavefront aberration. The measured refractive error can be used for reference when prescribing corrective lenses such as glasses or contact lenses. FDA UDI
- Model / Reference
- OPD-Scan III EUDAMEDFDA UDIB01E009 EUDAMED
- Description
- The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refractive error, corneal curvature, shape of the anterior corneal surface (topography), and pupil size of the patient’s eye, and analyzes wavefront aberration. The measured refractive error can be used for reference when prescribing corrective lenses such as glasses or contact lenses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100776 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669208GG EUDAMED
- FDA Product Code
- HLQ FDA UDIHKO FDA UDI
- EMDN Code
- Z12120123,Z12120199,Z1212020599 EUDAMED
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1350 FDA UDI886.1760 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III by Nidek Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4987669208GG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (2)
- EUDAMED 0cf5e072-cd73-492e-bb4c-8bb9d3e04c07 61 fields · synced Jun 18, 2026
- FDA UDI f3db53c8-57a9-4fb1-bcea-3d84c48fedcd 34 fields · synced May 30, 2026