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Kay Pictures Ltd iSight Pro
EUDAMEDClass I (EU MDR)
Ref iSightProModel iSight Pro
by Kay Pictures
Identity
- Trade Name
- Kay Pictures Ltd iSight Pro EUDAMED
- Device Name
- Kay iSight Test Professional App EUDAMED
- Model / Reference
- iSight Pro EUDAMEDiSightPro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060504460989 EUDAMED
- Basic UDI-DI
- 506050446VisTstSoftwareTL EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Greece 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
Kay Pictures Ltd iSight Pro by Kay Pictures — 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 | 506050446VisTstSoftwareTL | Class I | Active |
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Manufacturer
- Manufacturer
- Kay Pictures
- EUDAMED SRN
- GB-MF-000012744
- Authorised Representative
- Comply Express Lda PT-AR-000004357
Sources (1)
- EUDAMED f9f3367e-8df4-457d-8052-6761085e9ea3 61 fields · synced Jul 30, 2026