Identity
- Trade Name
- KOWA nonmyd AF FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic. FDA UDI
- Model / Reference
- K9L64K FDA UDI
- Description
- KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987646809128 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
KOWA nonmyd AF by Kowa Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Kowa Co. , Ltd.
Sources (1)
- FDA UDI a0efde9b-0e2a-47f6-a32f-64e82fbbbb73 34 fields · synced Jun 8, 2026