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Vx650

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref VX650510(k) K202221

by Luneau Technology Operations

Identity

Trade Name
VX650 EUDAMED
Visionix VX650 FDA UDI
Generic Name
Automated ophthalmic refractometer FDA UDI
Device Name
VX650 EUDAMED
Model / Reference
VX650 EUDAMEDFDA UDI

Identifiers

Catalog Number
10005844 FDA UDI
Primary DI / UDI-DI
03664188000145 EUDAMEDFDA UDI
Basic UDI-DI
13664188000145LP EUDAMED
Direct Marketing DI
03664188000145 EUDAMED
FDA Product Code
HKI FDA UDI
HKX FDA UDI
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
GMDN Term
Automated ophthalmic refractometer FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
886.1120 FDA UDI
886.1930 FDA UDI
Market of Registration
France 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

Vx650 by Luneau Technology Operations — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Luneau Technology Operations
EUDAMED SRN
FR-MF-000009091

Sources (3)

  • EUDAMED 5ebd8b4d-51d3-436a-b8cd-623d458bcda9 85 fields · synced Jun 18, 2026
  • FDA UDI b35a7d72-d2dc-4f7a-988a-4cdf53da12f0 33 fields · synced May 30, 2026
  • FDA 510(k) K202221 1 fields · synced May 18, 2026