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Chart Projector Cp-9
EUDAMEDFDA UDIClass I (EU MDR)
Ref CP009-0CCF,CP009-0G30,CP009-0G60,CP009-0K30,CP009-0M50,CP009-0T30,CP009-0T3F,CP009-0Z30Model CP-9, SC-1600, SSC-370
Identity
- Trade Name
- CHART PROJECTOR CP-9 EUDAMEDCHART PROJECTOR FDA UDI
- Generic Name
- Visual acuity projector FDA UDI
- Device Name
- The Nidek CHART PROJECTOR CP-9 is a chart presenting device that can achieve refraction at a distance of 2.9 m to 6.1 m (standard 5 m). The main unit is operated by a wireless remote control or the control box on a motorized refractor (RT). FDA UDI
- Model / Reference
- CP-9, SC-1600, SSC-370 EUDAMEDCP009-0CCF,CP009-0G30,CP009-0G60,CP009-0K30,CP009-0M50,CP009-0T30,CP009-0T3F,CP009-0Z30 EUDAMEDCP-9 FDA UDI
- Description
- The Nidek CHART PROJECTOR CP-9 is a chart presenting device that can achieve refraction at a distance of 2.9 m to 6.1 m (standard 5 m). The main unit is operated by a wireless remote control or the control box on a motorized refractor (RT). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101575 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669105G5 EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Visual acuity projector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 FDA UDI
- Market of Registration
- Germany 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
No
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
Chart Projector Cp-9 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 c55977b6-059f-418b-aa42-4dc0d07da32e 61 fields · synced Jun 19, 2026
- FDA UDI 3339a373-b5cb-4cd3-9342-1aaeca221a4f 34 fields · synced May 30, 2026
- EUDAMED c55977b6-059f-418b-aa42-4dc0d07da32e-1 61 fields · synced Jun 10, 2026