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Space Saving Chart Ssc-370
EUDAMEDFDA UDIClass I (EU MDR)
Ref 33292-0040,33292-0050,33292-0060,33292-00M0,33292-0340,33292-0360,33292-0660,33292-0940,33292-0960,33292-0S60Model CP-9, SC-1600, SSC-370
Identity
- Trade Name
- SPACE SAVING CHART SSC-370 EUDAMEDSPACE SAVING CHART FDA UDI
- Generic Name
- Vision testing/training chart FDA UDI
- Device Name
- The space saving chart SSC-370 achieves the refraction distance of 5 m within an installation distance*1 of 1.1 m. The SSC-370 is a chart presenting device. The built-in optical system presents charts toward the back of the chart window. The VA (visual acuity) charts are composed of the four types of letters, Tumbling E, number, and children. FDA UDI
- Model / Reference
- CP-9, SC-1600, SSC-370 EUDAMED33292-0040,33292-0050,33292-0060,33292-00M0,33292-0340,33292-0360,33292-0660,33292-0940,33292-0960,33292-0S60 EUDAMEDSSC-370 FDA UDI
- Description
- The space saving chart SSC-370 achieves the refraction distance of 5 m within an installation distance*1 of 1.1 m. The SSC-370 is a chart presenting device. The built-in optical system presents charts toward the back of the chart window. The VA (visual acuity) charts are composed of the four types of letters, Tumbling E, number, and children. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100646 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
- Denmark 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
Space Saving Chart Ssc-370 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 53f20ef9-af1b-4d87-a4f3-0c5104b566ba 61 fields · synced Jul 21, 2026
- FDA UDI f3a25178-720c-4c4a-a222-407c9156f386 34 fields · synced May 30, 2026
- EUDAMED 53f20ef9-af1b-4d87-a4f3-0c5104b566ba-1 61 fields · synced Jun 9, 2026