Identity
- Trade Name
- HUVITZ EUDAMEDHuvitz Integrated Image Server HIIS-1 FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- Integrated Image Server EUDAMEDThis software (HIIS-1) is a web-based software that can store, analyze, print and transmit the medical images and refraction data of patients acquired from ophthalmic devices on the computer where the software is installed. FDA UDI
- Model / Reference
- HIIS-1 EUDAMEDFDA UDISWXXCL-21-00001 EUDAMED
- Description
- This software (HIIS-1) is a web-based software that can store, analyze, print and transmit the medical images and refraction data of patients acquired from ophthalmic devices on the computer where the software is installed. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019600794 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196IS001E6 EUDAMED
- Direct Marketing DI
- 08800019600794 EUDAMED
- FDA Product Code
- NFJ FDA UDI
- EMDN Code
- Z12129092 VARIOUS OPHTALMOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
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 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 | 88000196IS001E6 | 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 dcc7ea94-0683-497f-91bd-c3f439a028d3 61 fields · synced Jul 11, 2026
- FDA UDI 2897d007-3fbb-401b-9f5f-47d679deddbb 33 fields · synced May 24, 2026