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Refractor Rt-3100

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 34090-0S20,34090-0U20,36301-0N41,36301-0ND1,36301-0S41,36301-0SD1,36320-0N40,36320-0ND0,Model RT-6100,RT-3100,TS-310

by NIDEK.CO.Ltd.,

Identity

Trade Name
REFRACTOR RT-3100 EUDAMED
REFRACTOR FDA UDI
Generic Name
Phoropter FDA UDI
Device Name
The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/ KER/TONOMETER (RKT), or AUTO LENSMETER (LM) via Eye Care card. The RT-3100 includes a refractor head, control box, and relay box. The relay box not only connects the other two units, but also connects the Chart Presenting device or PC. The control box includes the key panel, display, and printer. The display is a touch-screen panel. The control box displays the data and can be used for almost all operations. In addition, the control box operates the refractor head and the connected chart presenting device. It allows the refractor and charts to be controlled together. Normally, the relay box is installed on the system table (not included in the RT-3100 package.) FDA UDI
Model / Reference
RT-6100,RT-3100,TS-310 EUDAMED
34090-0S20,34090-0U20,36301-0N41,36301-0ND1,36301-0S41,36301-0SD1,36320-0N40,36320-0ND0, EUDAMED
RT-3100 FDA UDI
Description
The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/ KER/TONOMETER (RKT), or AUTO LENSMETER (LM) via Eye Care card. The RT-3100 includes a refractor head, control box, and relay box. The relay box not only connects the other two units, but also connects the Chart Presenting device or PC. The control box includes the key panel, display, and printer. The display is a touch-screen panel. The control box displays the data and can be used for almost all operations. In addition, the control box operates the refractor head and the connected chart presenting device. It allows the refractor and charts to be controlled together. Normally, the relay box is installed on the system table (not included in the RT-3100 package.) FDA UDI

Identifiers

Primary DI / UDI-DI
04987669100813 EUDAMEDFDA UDI
Basic UDI-DI
4987669104G3 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
Belgium 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

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-3100 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

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Manufacturer

Manufacturer
NIDEK.CO.Ltd.,
EUDAMED SRN
JP-MF-000040151
Authorised Representative
NIDEK SA FR-AR-000000341

Sources (3)

  • EUDAMED be04e8c2-b0b2-49d4-8597-fa8d4766a6cf 61 fields · synced Jun 18, 2026
  • FDA UDI c3f986af-1115-4dc3-af5f-434adb47dd45 34 fields · synced May 29, 2026
  • EUDAMED be04e8c2-b0b2-49d4-8597-fa8d4766a6cf-1 61 fields · synced Jun 10, 2026