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Eye-Tracking Perimeter FIELDNavigator
EUDAMEDClass I (EU MDR)
Ref FD000Model GAP2-HMD
by FINDEX Inc.
Identity
- Trade Name
- Eye-Tracking Perimeter FIELDNavigator EUDAMED
- Device Name
- Eye-Tracking Perimeter FIELDNavigator EUDAMED
- Model / Reference
- GAP2-HMD EUDAMEDFD000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582515320089 EUDAMED
- Basic UDI-DI
- 458251532GAPH00001M5 EUDAMED
- EMDN Code
- Z1212012003 PERIPHERAL VISION ANALYSERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Perimeter, automatic
Eye-Tracking Perimeter FIELDNavigator by FINDEX Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 458251532GAPH00001M5 | Class I | Active |
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Manufacturer
- Manufacturer
- FINDEX Inc.
- EUDAMED SRN
- JP-MF-000028068
- Authorised Representative
- Rexxam Co., Ltd. Netherlands Office NL-AR-000002643
Sources (1)
- EUDAMED 16425cab-1532-4488-965b-b1583995a289 61 fields · synced Jun 18, 2026