Identity
- Trade Name
- LuxOR EUDAMEDFDA UDILuxOR Revalia FDA UDI
- Generic Name
- Ophthalmic surgical microscope FDA UDI
- Device Name
- Ophthalmic Microscopes EUDAMEDSurgical Microscope System FDA UDISurgical Microscope FDA UDI
- Model / Reference
- 8065753071 EUDAMED00380657525607 FDA UDI00380657530717 FDA UDI
- Description
- Surgical Microscope System FDA UDISurgical Microscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657530717 EUDAMEDFDA UDI00380657525607 FDA UDI
- Basic UDI-DI
- 038065GMN000203GT EUDAMED
- FDA Product Code
- HRM FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- Ophthalmic surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Market of Registration
- Belgium 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
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
Yes
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 surgical microscope
LuxOR by Alcon Laboratories, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (3)
- FDA UDI 29244cef-5596-42a9-b914-eb07f80dccbf 33 fields · synced Aug 1, 2026
- FDA UDI fbd491cc-5600-430b-aab3-b98f41f3ec0e 33 fields · synced May 30, 2026
- EUDAMED 641f38e8-2f00-4c78-b306-3b4d008d1f6b 61 fields · synced Aug 1, 2026