Identity
- Trade Name
- NEXY FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B667NEXY1 FDA UDI
- FDA Product Code
- HKI 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
No
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
Nexy by Next Sight Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic fundus camera.
- RetCam Portable — Natus Medical, Inc. · Class II
- 3nethra — FORUS HEALTH PRIVATE LIMITED · Class II
- 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
- Next Sight Srl
Sources (1)
- FDA UDI 3fc8b5d5-a762-449b-9440-862ae118dd73 33 fields · synced May 30, 2026