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EliteVue head only, LED, 3.5V, with anti-theft

FDA UDI

Class I (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name
EliteVue head only, LED, 3.5V, with anti-theft FDA UDI
Generic Name
Otoscope, direct FDA UDI
Device Name
The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula FDA UDI
Model / Reference
10512-301 FDA UDI
Description
The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula FDA UDI

Identifiers

Catalog Number
10512-301 FDA UDI
Primary DI / UDI-DI
04045396213395 FDA UDI
510(k) Number
K932506 FDA UDI
FDA Product Code
ERA FDA UDI
GMDN Term
Otoscope, direct 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: Otoscope, direct

EliteVue head only, LED, 3.5V, with anti-theft by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Otoscope, direct.

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 4d0e7b7f-e8b8-455e-ac9e-b7a45659b17d 35 fields · synced May 30, 2026