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Data Acquisition Service for NAVIS-EX
FDA UDIClass II (US FDA UDI)
by Nidek, Inc.
Identity
- Trade Name
- Data Acquisition Service for NAVIS-EX FDA UDI
- Generic Name
- Eye anterior segment analyser software FDA UDI
- Device Name
- Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX. In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX. In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101421 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- GMDN Term
- Eye anterior segment analyser software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Eye anterior segment analyser software
Data Acquisition Service for NAVIS-EX by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Eye anterior segment analyser software.
- ANTERION — Heidelberg Engineering · Class II
- Image filing software NAVIS-EX — Nidek, Inc. · Class I
- AL-Scan Viewer for NAVIS-EX — Nidek, Inc. · Class II
- AL-Scan Viewer for NAVIS-EX — Nidek, Inc. · Class II
- CEM Viewer for NAVIS-EX — Nidek, Inc. · Class II
- CEM Viewer for NAVIS-EX — Nidek, Inc. · Class II
- Image filing software — Nidek, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI be427391-a792-4e3b-8921-9edd193c0a13 34 fields · synced Jun 8, 2026