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Visuref 600
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 000000-2572-424510(k) K253834
Identity
- Trade Name
- VISUREF 600 EUDAMED
- Device Name
- VISUREF 600 EUDAMED
- Model / Reference
- 000000-2572-424 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250668607202 EUDAMED
- Basic UDI-DI
- 42506686-B01-VR600-87 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Visuref 600 by Carl Zeiss Vision Gmbh — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253834 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 42506686-B01-VR600-87 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Vision GmbH
- EUDAMED SRN
- DE-MF-000006173
Sources (2)
- EUDAMED 765cd017-7d8b-40fe-880c-6f0b4a51a7b5 85 fields · synced Jun 18, 2026
- FDA 510(k) K253834 1 fields · synced May 18, 2026