Identity
- Trade Name
- VISUSCREEN 500 EUDAMEDFDA UDI
- Generic Name
- Visual acuity projector FDA UDI
- Device Name
- VISUSCREEN 500 EUDAMEDN/A FDA UDI
- Model / Reference
- 000000-2087-230 EUDAMEDFDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- 000000-2087-230 FDA UDI
- Primary DI / UDI-DI
- 04250668606724 EUDAMEDFDA UDI
- Basic UDI-DI
- 42506686-B01-VS500-8B EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Visual acuity projector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 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
Visuscreen 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-B01-VS500-8B | 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 605a3754-7719-49a5-b4db-cd48b734c56f 61 fields · synced Aug 1, 2026
- FDA UDI d4c9aba7-0783-4e28-a425-86ae63c73b7c 36 fields · synced May 30, 2026