Identity
- Trade Name
- VISUREF 1000 EUDAMEDZEISS FDA UDI
- Generic Name
- Multiple ocular dimension meter FDA UDI
- Device Name
- VISUREF 1000 EUDAMED
- Model / Reference
- VX650 EUDAMEDVISUREF 1000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000589 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000589MX EUDAMED
- Direct Marketing DI
- 03664188000589 EUDAMED
- FDA Product Code
- HKI FDA UDIHKX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Multiple ocular dimension meter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1120 FDA UDI886.1930 FDA UDI
- Market of Registration
- Hungary 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Visuref 1000 by Luneau Technology Operations — Class IIa — 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 | 13664188000589MX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
- EUDAMED SRN
- FR-MF-000009091
Sources (2)
- EUDAMED 90714d94-02fc-4316-90eb-47b46cb337cf 61 fields · synced Aug 2, 2026
- FDA UDI 1320e0dc-d0c8-4ebc-a10c-e17407d40ff6 32 fields · synced May 30, 2026