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ExamVision Loupe System Galilean Essential 2.5x
EUDAMEDClass I (EU MDR)
Ref ESS25BIORef ESS25
Identity
- Trade Name
- ExamVision Loupe System Galilean Essential 2.5x EUDAMEDEssential 2.5x EUDAMED
- Device Name
- ExamVision Loupe System EUDAMED
- Model / Reference
- ESS25BIO EUDAMEDESS25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05744000230047 EUDAMED05744000230030 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 Galilean Essential 2.5x 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 (2)
- EUDAMED 3cf28b92-1ee4-4092-b690-5930be0594f3 61 fields · synced Jul 31, 2026
- EUDAMED e2a99dc0-574c-4edb-bce3-6a2ae41ab736 61 fields · synced May 18, 2026