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Scanning Laser Ophthalmoscope Mirante
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SR002-0040,SR002-0S40,Model RS-1,Mirante,RS-3000 Advance
Identity
- Trade Name
- Scanning Laser Ophthalmoscope Mirante EUDAMEDScanning Laser Ophthalmoscope FDA UDI
- Generic Name
- Scanning-laser retinal imaging system FDA UDI
- Device Name
- The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”). FDA UDI
- Model / Reference
- RS-1,Mirante,RS-3000 Advance EUDAMEDSR002-0040,SR002-0S40, EUDAMEDMirante FDA UDI
- Description
- The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101568 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987669216GF EUDAMED
- FDA Product Code
- OBO FDA UDIMYC FDA UDINFJ FDA UDI
- EMDN Code
- Z12120121,Z12120199 EUDAMED
- GMDN Term
- Scanning-laser retinal imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI892.2050 FDA UDI
- Market of Registration
- Denmark 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
Scanning Laser Ophthalmoscope Mirante by Nidek Co., Ltd. — 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 | 4987669216GF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 a8c81dfb-1a2b-4526-9284-3d3f2de0c883 61 fields · synced May 30, 2026
- FDA UDI 06fcfd7d-c27a-4405-95e4-2b2b77781832 34 fields · synced May 30, 2026