Identity
- Device Name
- Vision Screener EUDAMED
- Model / Reference
- HVS-1 EUDAMEDAAXXCL-24-00001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019600954 EUDAMED
- Basic UDI-DI
- 88000196VS001JM EUDAMED
- Direct Marketing DI
- 08800019600954 EUDAMED
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Vision Screener by Huvitz Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000196VS001JM | Class I | Active |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 52e61044-53f4-479c-9a8a-d68eb36bf9fd 61 fields · synced Jul 11, 2026