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System Chart Sc-1600
EUDAMEDFDA UDIClass I (EU MDR)
Ref 34607-0040,34607-0080,34607-0P40Model CP-9, SC-1600, SSC-370
Identity
- Trade Name
- SYSTEM CHART SC-1600 EUDAMEDSYSTEM CHART FDA UDI
- Generic Name
- Vision testing/training chart FDA UDI
- Device Name
- The SYSTEM CHART SC-1600 is a chart presenting device that displays the charts on an LCD. The charts are controlled by an optional remote control or the control box of the NIDEK refractor*1. In contrast to a chart presenting device which projects the charts from film, the SC-1600 displays the digitally stored chart shapes on the LCD. This makes the following possible. FDA UDI
- Model / Reference
- CP-9, SC-1600, SSC-370 EUDAMED34607-0040,34607-0080,34607-0P40 EUDAMEDSC-1600 FDA UDI
- Description
- The SYSTEM CHART SC-1600 is a chart presenting device that displays the charts on an LCD. The charts are controlled by an optional remote control or the control box of the NIDEK refractor*1. In contrast to a chart presenting device which projects the charts from film, the SC-1600 displays the digitally stored chart shapes on the LCD. This makes the following possible. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100653 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669105G5 EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Vision testing/training chart FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 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
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 Chart Sc-1600 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 | 4987669105G5 | 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 4355d124-7a34-4a2e-b84b-24ebda82a2d1 61 fields · synced Jul 18, 2026
- FDA UDI b74c6f96-c273-454f-ad07-5e94629a0df9 34 fields · synced May 30, 2026
- EUDAMED 4355d124-7a34-4a2e-b84b-24ebda82a2d1-1 61 fields · synced Jun 10, 2026