Identity
- Trade Name
- HUVITZ EUDAMEDFundus Camera HFC-1 FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- Fundus Camera EUDAMEDHFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health. FDA UDI
- Model / Reference
- HFC-1 EUDAMEDFDA UDIW2XXCL-21-00009 EUDAMED
- Description
- HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health. FDA UDI
Identifiers
- Catalog Number
- HFC-1 FDA UDI
- Primary DI / UDI-DI
- 08800019600541 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196FC0019M EUDAMED
- Direct Marketing DI
- 08800019600541 EUDAMED
- 510(k) Number
- K202097 FDA UDI
- FDA Product Code
- HKI FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 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
Yes
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
No
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 IIa — 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 | 88000196FC0019M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 80f804dd-2a44-4d45-953a-ac20db61a29d 61 fields · synced Jun 8, 2026
- FDA UDI 80c408b8-0f0a-4fae-b8c8-7b001e17245a 36 fields · synced May 30, 2026