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Refractor Rt-6100
EUDAMEDFDA UDIClass I (EU MDR)
Ref 36301-0M41,36301-0MD1,36301-0Q41,36301-0QD1,36320-0M40,36320-0MD0,RT015-0U40,RT015-0UD0Model RT-6100,RT-3100,TS-310
Identity
- Trade Name
- REFRACTOR RT-6100 EUDAMEDREFRACTOR FDA UDI
- Generic Name
- Vision testing/training chart FDA UDI
- Device Name
- The RT-6100 is a motorized refractor for subjective refraction designed to be connected with other Nidek products such as the Auto Refractometer and/or Lensmeter to import their measurement data. Measurement of refractive errors (spherical power, cylindrical power, and cylinder axis) and binocular visual function testing are performed according to the patient’s response. FDA UDI
- Model / Reference
- RT-6100,RT-3100,TS-310 EUDAMED36301-0M41,36301-0MD1,36301-0Q41,36301-0QD1,36320-0M40,36320-0MD0,RT015-0U40,RT015-0UD0 EUDAMEDRT-6100 FDA UDI
- Description
- The RT-6100 is a motorized refractor for subjective refraction designed to be connected with other Nidek products such as the Auto Refractometer and/or Lensmeter to import their measurement data. Measurement of refractive errors (spherical power, cylindrical power, and cylinder axis) and binocular visual function testing are performed according to the patient’s response. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101445 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669104G3 EUDAMED
- FDA Product Code
- HOX FDA UDIHKN FDA UDI
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
- GMDN Term
- Vision testing/training chart FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 FDA UDI886.1770 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
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
Refractor Rt-6100 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 | 4987669104G3 | 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 (3)
- EUDAMED d0a7a9f3-ac58-4ab8-92d0-c5b21c020177 61 fields · synced Jul 15, 2026
- FDA UDI 8faf4599-8c2d-4b02-9e89-dca0c2ef7843 35 fields · synced May 27, 2026
- EUDAMED d0a7a9f3-ac58-4ab8-92d0-c5b21c020177-1 61 fields · synced Jun 10, 2026