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ri-scope®L ophthalmoscope head L2 LED 2, 5 V

FDA UDI

Class I (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name
ri-scope®L ophthalmoscope head L2 LED 2,5 V FDA UDI
Generic Name
Ophthalmic/otologic diagnostic set FDA UDI
Device Name
The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. FDA UDI
Model / Reference
10597 FDA UDI
Description
The Riester ophthalmoscope is produced for the examination of the eye and the eyeground. FDA UDI

Identifiers

Catalog Number
10597 FDA UDI
Primary DI / UDI-DI
04045396209275 FDA UDI
510(k) Number
K932506 FDA UDI
FDA Product Code
ERA FDA UDI
GMDN Term
Ophthalmic/otologic diagnostic set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4770 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: Ophthalmic/otologic diagnostic set

ri-scope®L ophthalmoscope head L2 LED 2, 5 V by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic/otologic diagnostic set.

Cleared under the same submission

K932506 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rudolf Riester GmbH & Co. KG

Sources (1)

  • FDA UDI e7872e7b-8f64-4679-8dfa-9ca3a0fffbc3 35 fields · synced May 30, 2026