Identity
- Trade Name
- ExamVision Loupe System Kepler Kompakt 5.7x EUDAMED
- Device Name
- ExamVision Loupe System EUDAMED
- Model / Reference
- KK57 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05744000230337 EUDAMED
- Basic UDI-DI
- 574400023EVLoupeXD EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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: Surgical binoculars, reusable
ExamVision Loupe System Kepler Kompakt 5.7x by ExamVision A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical binoculars, reusable.
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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 | 574400023EVLoupeXD | Class I | Active |
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Manufacturer
- Manufacturer
- ExamVision A/S
- EUDAMED SRN
- DK-MF-000032397
Sources (1)
- EUDAMED 37dd8266-e4cd-4e77-be51-dde64c1a7b03 61 fields · synced Jul 29, 2026