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Digital Chart, Chart Projector, Visual Acuity Chart System
EUDAMEDFDA UDIClass I (EU MDR)
Ref C6XXCL-21-00001Model HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF
Identity
- Trade Name
- Digital Chart HDC-9100N FDA UDI
- Generic Name
- Vision testing/training chart FDA UDI
- Device Name
- Digital Chart, Chart Projector, Visual Acuity Chart System EUDAMEDDigital Chart HDC-9100N FDA UDI
- Model / Reference
- HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF EUDAMEDC6XXCL-21-00001 EUDAMEDHDC-9100N FDA UDI
- Description
- Digital Chart HDC-9100N FDA UDI
Identifiers
- Catalog Number
- HDC-9100N FDA UDI
- Primary DI / UDI-DI
- 08800019600732 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196DC0018X EUDAMED
- Direct Marketing DI
- 08800019600732 EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT 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
- 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
Yes
FDA UDI
Digital Chart, Chart Projector, Visual Acuity Chart System by Huvitz Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 88000196DC0018X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0331b90f-adc6-45f4-a063-9f2be8c54e21 61 fields · synced Jun 18, 2026
- FDA UDI 52dc6488-65db-4477-be47-d756bdc60560 35 fields · synced May 30, 2026