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Slit Lamp Sl-2000
EUDAMEDFDA UDIClass I (EU MDR)
Ref B01E003Model SL-1800, SL-2000, SL-250, SL-450
Identity
- Trade Name
- SLIT LAMP SL-2000 EUDAMEDSlit Lamp FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light. FDA UDI
- Model / Reference
- SL-1800, SL-2000, SL-250, SL-450 EUDAMEDB01E003 EUDAMEDSL-2000 FDA UDI
- Description
- The NIDEK SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101377 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669101FV 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
- 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
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
No
FDA UDI
Slit Lamp Sl-2000 by Nidek Co., Ltd. — 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 | 4987669101FV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (2)
- EUDAMED c6ecbc6d-4027-4494-94df-dbb5d6f2ecb5 61 fields · synced Jul 10, 2026
- FDA UDI cd6ee053-b35d-4864-8ddb-36ff77dcd95e 34 fields · synced May 30, 2026