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Slit Lamp Sl-1800
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref B01E014Model SL-1800, SL-2000, SL-250, SL-450510(k) K163564
Identity
- Trade Name
- SLIT LAMP SL-1800 EUDAMED
- Model / Reference
- SL-1800, SL-2000, SL-250, SL-450 EUDAMEDB01E014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669200650 EUDAMED
- Basic UDI-DI
- 4987669101FV EUDAMED
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Slit Lamp Sl-1800 by Nidek Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163564 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4987669101FV | Class I | Active |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- FDA Applicant
- Nidek Co., Ltd.
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (2)
- EUDAMED 57104f22-7dcf-4354-bad5-7277b3d0f5c4 85 fields · synced Jun 18, 2026
- FDA 510(k) K163564 1 fields · synced May 18, 2026