Identity
- Trade Name
- SL 500 EUDAMEDESSILOR SL500L FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- SLIT LAMP EUDAMEDStereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye). FDA UDI
- Model / Reference
- SL500 EUDAMEDSL500L FDA UDI
- Description
- Stereomicroscopic observation of the eye subjected to light through a slot Microscopic study of the fundus and posterior vitreous (via a lens Hubry) The ophthalmic evaluation and positioning of the contact lens This product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615020000359 EUDAMEDFDA UDI
- Basic UDI-DI
- 361502000000ISLITLAMP00L5 EUDAMED
- FDA Product Code
- HJO FDA UDI
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- Austria EUDAMEDFrance 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sl 500 by Essilor International — Class I — 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 | 361502000000ISLITLAMP00L5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Essilor International
- EUDAMED SRN
- FR-MF-000007175
Sources (3)
- EUDAMED bf795208-2d1a-4ffd-aa1b-c04652aa55d2 61 fields · synced Jun 19, 2026
- FDA UDI 1b37aa0f-395a-4a53-8431-378c69440382 35 fields · synced May 30, 2026
- EUDAMED 8f60300c-1e60-45c1-9674-01c6c0c2bc89 61 fields · synced Jun 19, 2026