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System Table ST-600
EUDAMEDFDA UDIClass I (EU MDR)
Ref 36320-0P40Model ST-600,ST-6100
Identity
- Trade Name
- System Table ST-600 EUDAMEDSystem Table FDA UDI
- Generic Name
- Instrument table FDA UDI
- Device Name
- The ST-600 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 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) 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 200 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 35 types of trial lenses. FDA UDI
- Model / Reference
- ST-600,ST-6100 EUDAMED36320-0P40 EUDAMEDST-600 FDA UDI
- Description
- The ST-600 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 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) 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 200 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 35 types of trial lenses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101490 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
- Norway 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
System Table ST-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 | 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 (2)
- EUDAMED c32e7d50-8c92-4937-a87a-0293cce1c163 61 fields · synced Jun 19, 2026
- FDA UDI f797b8a7-e58f-4f75-9c4f-7af3f3c88be1 35 fields · synced May 29, 2026