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Cc-100 Hw6.0
EUDAMEDFDA UDIClass I (EU MDR)
Ref 42-0000087Model CC-100 HW6.0 / CC-100XP HW6.0Ref 42-0002866
Identity
- Trade Name
- CC-100 HW6.0 EUDAMEDTOPCON FDA UDI
- Generic Name
- Visual acuity projector FDA UDI
- Device Name
- CC-100 HW6.0 Series EUDAMEDinstrument intended for use by an optometric/ ophthalmic professional for the analysis of visual acuity FDA UDI
- Model / Reference
- CC-100 HW6.0 / CC-100XP HW6.0 EUDAMED42-0000087 EUDAMED42-0002866 EUDAMEDCC-100 FDA UDI
- Description
- instrument intended for use by an optometric/ ophthalmic professional for the analysis of visual acuity FDA UDI
Identifiers
- Catalog Number
- 120503300 FDA UDI
- Primary DI / UDI-DI
- 08034028770319 EUDAMEDFDA UDI08034028770555 EUDAMED
- Basic UDI-DI
- 803402877VISUALCHART1L6 EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – 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
- Italy 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
Cc-100 Hw6.0 by Visia Imaging Srl — 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 | 803402877VISUALCHART1L6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Visia imaging SRL
- EUDAMED SRN
- IT-MF-000015628
Sources (3)
- EUDAMED b39c914e-a5f0-461a-84c9-5e225d461aa4 61 fields · synced Jul 12, 2026
- EUDAMED 84d2957e-ad2c-4937-9420-bda5705fdc39 61 fields · synced May 18, 2026
- FDA UDI 86514784-0fd7-4e53-a5bf-716b901ebba9 34 fields · synced May 30, 2026