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Cc-100 Hw6.0
EUDAMEDFDA UDIClass I (EU MDR)
Ref 300200Model CC-100 HW6.0 / CC-100XP HW6.0
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 EUDAMED300200 EUDAMEDCC-100 HW6.0 FDA UDI
- Description
- instrument intended for use by an optometric/ ophthalmic professional for the analysis of visual acuity FDA UDI
Identifiers
- Catalog Number
- 300200 FDA UDI
- Primary DI / UDI-DI
- 08034028770562 EUDAMEDFDA UDI
- 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
- 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 (2)
- EUDAMED 01f6192e-d00a-4725-b7f0-34df68ffcee1 61 fields · synced Jul 28, 2026
- FDA UDI ea1904b4-84b1-4551-8bb6-02f76483d2cc 34 fields · synced May 30, 2026