Identity
- Trade Name
- REFRACTOR RT-600 EUDAMEDREFRACTOR FDA UDI
- Generic Name
- Phoropter FDA UDI
- Device Name
- NIDEK Model RT-600 has been developed to renovate the conventional refractor, assuming a new aspect, to turn the thought of the people who used the conventional model, to an entirely different subjective refractor, easy to master with the highest accuracy. FDA UDI
- Model / Reference
- RT-600 EUDAMEDFDA UDI33863-0040 EUDAMED
- Description
- NIDEK Model RT-600 has been developed to renovate the conventional refractor, assuming a new aspect, to turn the thought of the people who used the conventional model, to an entirely different subjective refractor, easy to master with the highest accuracy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101711 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669103FZ EUDAMED
- FDA Product Code
- HKN FDA UDI
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
- GMDN Term
- Phoropter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1770 FDA UDI
- Market of Registration
- France 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Refractor Rt-600 by Nidek Co., Ltd. — Class I — 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 | 4987669103FZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 b67b9175-c6b0-48c2-a751-50b6422f6bdd 61 fields · synced Jun 20, 2026
- FDA UDI ece385c8-885b-4c19-896e-0882cbf10600 34 fields · synced May 30, 2026