Identity
- Trade Name
- JEDMED FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- BATTERY F/HORUS +DIGITAL OTOSCOPE FDA UDI
- Model / Reference
- 39-7408 FDA UDI
- Description
- BATTERY F/HORUS +DIGITAL OTOSCOPE FDA UDI
Identifiers
- Catalog Number
- 39-7408 FDA UDI
- Primary DI / UDI-DI
- M6333974080 FDA UDI
- 510(k) Number
- K120982 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic fundus camera
Jedmed by JEDMED Instrument Company — 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
Cleared under the same submission
K120982 also covers:
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
- JEDMED — JEDMED Instrument Company
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JEDMED Instrument Company
Sources (1)
- FDA UDI 2079db83-155e-4f75-890d-e44349825148 35 fields · synced May 30, 2026