Identity
- Trade Name
- e-scope® ophthalmoscope LED 3.7 V, black, FDA UDI
- Generic Name
- Direct ophthalmoscope FDA UDI
- Device Name
- The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. FDA UDI
- Model / Reference
- 2123-203 FDA UDI
- Description
- The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. FDA UDI
Identifiers
- Catalog Number
- 2123-203 FDA UDI
- Primary DI / UDI-DI
- 04045396177000 FDA UDI
- 510(k) Number
- K925757 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Direct ophthalmoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 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
No
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
Yes
FDA UDI
Category: Direct ophthalmoscope
e-scope® ophthalmoscope LED 3.7 V, black, by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Direct ophthalmoscope.
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- Amico Diagnostic Station — Amico Diagnostic Incorporated · Class I
- HEINE EN 100® Diagnostic Center — Heine Optotechnik GmbH & Co. KG · Class II
- HEINE mini 3000® LED F.O. Diagnostic Set — Heine Optotechnik GmbH & Co. KG · Class II
- Amico Diagnostic Station — Amico Diagnostic Incorporated · Class II
- JEDMED — JEDMED Instrument Company · Class II
Cleared under the same submission
K925757 also covers:
- e-scope® ophthalmoscope LED 3.7 V, white, — Rudolf Riester GmbH & Co. KG
- e-scope® ophthalmoscope XL 2.5 V, black, — Rudolf Riester GmbH & Co. KG
- e-scope® ophthalmoscope XL 2.5 V, white, — Rudolf Riester GmbH & Co. KG
- e-scope® ophthalmoscope xenon 2.5 V, black, — Rudolf Riester GmbH & Co. KG
- e-scope® ophthalmoscope xenon 2.5 V, white, — Rudolf Riester GmbH & Co. KG
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
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI 63e13c5b-6b9f-4d3e-8bf8-6e2ddbbf1ec7 35 fields · synced May 30, 2026