← Back to catalogue
Huvitz
EUDAMEDFDA UDIClass I (EU MDR)
Ref E2DDAG-21-00002Model HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF
Identity
- Trade Name
- HUVITZ EUDAMEDChart Projector HCP-7000 FDA UDI
- Generic Name
- Visual acuity projector FDA UDI
- Device Name
- Digital Chart, Chart Projector, Visual Acuity Chart System EUDAMEDchart projector is intended to be used to check eye optometry FDA UDI
- Model / Reference
- HDC-9100 N, HDC-9100 PF, HCP-7000, HDC-100, HDC-9000 N, HDC-9000 PF EUDAMEDE2DDAG-21-00002 EUDAMEDHCP-7000 FDA UDI
- Description
- chart projector is intended to be used to check eye optometry FDA UDI
Identifiers
- Catalog Number
- HCP-7000 FDA UDI
- Primary DI / UDI-DI
- 08800019600237 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196DC0018X EUDAMED
- Direct Marketing DI
- 08800019600237 EUDAMED
- FDA Product Code
- HOS FDA UDI
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
- GMDN Term
- Visual acuity projector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1680 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
Huvitz by Huvitz 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 | 88000196DC0018X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 72a70294-0e6d-4e4f-8c8b-799f1da69aae 61 fields · synced Jun 1, 2026
- FDA UDI dd0f8a9f-e967-4fc2-a8d3-17dafe796b47 35 fields · synced May 30, 2026