Identity
- Trade Name
- WAM 800 EUDAMEDESSILOR FDA UDI
- Generic Name
- Multiple ocular dimension meter FDA UDI
- Device Name
- WAM 800 EUDAMEDWAM800 is a multifunctional eye diagnostic device. FDA UDI
- Model / Reference
- WAM 800 EUDAMEDFDA UDIWAM800 EUDAMED
- Description
- WAM800 is a multifunctional eye diagnostic device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664188000565 EUDAMEDFDA UDI03664188000657 EUDAMED
- Basic UDI-DI
- 13664188000565MH EUDAMED
- Direct Marketing DI
- 03664188000565 EUDAMED03664188000657 EUDAMED
- FDA Product Code
- HKX FDA UDIHKO FDA UDIMXK 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 UDI886.1760 FDA UDI886.1850 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
Wam 800 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 | 13664188000565MH | 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 (4)
- EUDAMED f986db78-dd72-4482-a3d6-dd5becf333c6 61 fields · synced Jul 12, 2026
- FDA UDI d3d6dd62-9f0c-46c9-91c8-fd2300dc45c0 33 fields · synced May 30, 2026
- EUDAMED a7e7d82b-db59-4544-8e37-46682cfac1fb 61 fields · synced Jun 14, 2026
- EUDAMED 5cb6ffc6-8959-44a0-93f5-5631044101fb 61 fields · synced Jul 8, 2026