System Table ST-6100

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 36301-0P41,36301-0T41Model ST-600,ST-6100

by NIDEK.CO.Ltd.,

Identity

Trade Name: System Table ST-6100 EUDAMED
System Table FDA UDI
Generic Name: Instrument table FDA UDI
Device Name: The ST-6100 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually operated refractor such as the RT-600 or SLY-100*1 is installed. The system table allows chart presenting devices (SSC-370, CP-770, SC-1600 series), auto refractometers, lensmeters (LM-1800 series, LM-7 series), and slit lamp (SL-1800 TAKAGI M2/M4) to be combined into an ophthalmic workstation. The system table consists of a refractor head lift arm equipped with a refractor head and a motorized main table. While compact, it includes a motorized table with a stroke up to 180 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 40 types of trial lenses. Trays for mounting an auto refractometer, or for mounting a slit lamp and auto refractometer are also available. FDA UDI
Model / Reference: ST-600,ST-6100 EUDAMED
36301-0P41,36301-0T41 EUDAMED
ST-6100 FDA UDI
Description: The ST-6100 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually operated refractor such as the RT-600 or SLY-100*1 is installed. The system table allows chart presenting devices (SSC-370, CP-770, SC-1600 series), auto refractometers, lensmeters (LM-1800 series, LM-7 series), and slit lamp (SL-1800 TAKAGI M2/M4) to be combined into an ophthalmic workstation. The system table consists of a refractor head lift arm equipped with a refractor head and a motorized main table. While compact, it includes a motorized table with a stroke up to 180 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 40 types of trial lenses. Trays for mounting an auto refractometer, or for mounting a slit lamp and auto refractometer are also available. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987669101483 EUDAMEDFDA UDI
Basic UDI-DI: 4987669102FX EUDAMED
FDA Product Code: HRJ FDA UDI
EMDN Code: Z12129001 OPHTHALMOLOGICAL INSTRUMENT STANDS EUDAMED
GMDN Term: Instrument table FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 886.4855 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

System Table ST-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	4987669102FX	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 d81d458c-00b2-4ae5-8c66-6b320368d55d 61 fields · synced Jul 20, 2026
FDA UDI 6145b008-df39-402e-bb4a-c60c3fca82ae 35 fields · synced May 29, 2026
EUDAMED d81d458c-00b2-4ae5-8c66-6b320368d55d-1 61 fields · synced Jun 10, 2026