Identity
- Trade Name
- DIGITAL MEDICAL SCOPE FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. FDA UDI
- Model / Reference
- DS-20F FDA UDI
- Description
- NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669101001 FDA UDI
- FDA Product Code
- PJZ FDA UDI
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic fundus camera
Digital Medical Scope by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic fundus camera.
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- Welch Allyn — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
- iCam — OPTOVUE, INC. · Class II
- RetCam 3 — Natus Medical, Inc. · Class II
- Volk Pictor VP1ANT — VOLK OPTICAL INC. · Class II
- VISUCAM 224 — Carl Zeiss Meditec AG · Class II
- NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · Class II
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 d300130c-596f-4756-9dc3-5fc9fb4c67bf 34 fields · synced Jun 1, 2026