Identity
- Trade Name
- DNEye Scanner 3 EUDAMEDRODENSTOCK FDA UDI
- Generic Name
- Multiple ocular dimension meter FDA UDI
- Device Name
- DNEye Scanner 3 EUDAMED
- Model / Reference
- DNEye Scanner 3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000404 EUDAMEDFDA UDI
- Basic UDI-DI
- 13664188000404LQ EUDAMED
- FDA Product Code
- HKX FDA UDIMXK FDA UDIHKI 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
- 886.1930 FDA UDI886.1850 FDA UDI886.1120 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
Category: Ophthalmic fundus cameraMultiple ocular dimension meter
Rodenstock by Luneau Technology Operations — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple ocular dimension meter.
- RODENSTOCK — LUNEAU TECHNOLOGY OPERATIONS · Class II
- ESSILOR — LUNEAU TECHNOLOGY OPERATIONS · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
Sources (2)
- FDA UDI 861dbb98-6307-4da4-b152-fc72100f71ce 32 fields · synced Jun 19, 2026
- EUDAMED f13c2d4f-892a-421c-a3d8-5bd74c5b4705 61 fields · synced Jun 19, 2026