Identity
- Trade Name
- VISUCONSULT 500 EUDAMEDFDA UDI
- Generic Name
- Multidisciplinary medical image management software FDA UDI
- Device Name
- VISUCONSULT 500 EUDAMEDN/A FDA UDI
- Model / Reference
- 000000-2265-586 EUDAMEDFDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- 000000-2265-586 FDA UDI
- Primary DI / UDI-DI
- 04250668606618 EUDAMEDFDA UDI
- Basic UDI-DI
- 42506686-S02-VC500-JT EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Multidisciplinary medical image management software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Visuconsult 500 by Carl Zeiss Vision Gmbh — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42506686-S02-VC500-JT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Vision GmbH
- EUDAMED SRN
- DE-MF-000006173
Sources (2)
- EUDAMED fdd95610-4d3c-476e-9ed3-148fb61267b7 61 fields · synced Jun 18, 2026
- FDA UDI 02930b2c-9a79-48b7-b46f-203938e0eac2 35 fields · synced May 30, 2026