Identity
- Trade Name
- VISUFIT 1000 Platform EUDAMEDFDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- VISUFIT 1000 Platform EUDAMEDN/A FDA UDI
- Model / Reference
- 000000-2194-446 EUDAMEDFDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- 000000-2194-446 FDA UDI
- Primary DI / UDI-DI
- 04250668606663 EUDAMEDFDA UDI
- Basic UDI-DI
- 42506686-B01-VF1000P-Q3 EUDAMED
- FDA Product Code
- HMF FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1860 FDA UDI
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VISUFIT 1000 Platform 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-B01-VF1000P-Q3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carl Zeiss Vision GmbH
- EUDAMED SRN
- DE-MF-000006173
Sources (2)
- EUDAMED 2e00690c-790f-4ea2-8faa-898db2706d56 61 fields · synced Jun 18, 2026
- FDA UDI 91aada00-234b-4b83-bf99-dc5cbabf9066 36 fields · synced May 30, 2026