uni® I otoscope vacuum 2.7 V, C-handle

FDA UDI

Class I (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name: uni® I otoscope vacuum 2.7 V, C-handle FDA UDI
Generic Name: Otoscope, direct FDA UDI
Device Name: The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum. FDA UDI
Model / Reference: 2010 FDA UDI
Description: The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum. FDA UDI

Identifiers

Catalog Number: 2010 FDA UDI
Primary DI / UDI-DI: 04045396002739 FDA UDI
510(k) Number: K925759 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Otoscope, direct

uni® I otoscope vacuum 2.7 V, C-handle by Rudolf Riester GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Otoscope, direct.

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Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
BETA 200 VET. OTOSCOPE — Heine Optotechnik GmbH & Co. KG · Class I
Firefly — Firefly Global · Class I
Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
Welch Allyn, Inc. — Welch Allyn, Inc. · Class I

Cleared under the same submission

K925759 also covers:

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 I	Pending data

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Manufacturer

Manufacturer: Rudolf Riester GmbH & Co. KG

Sources (1)

FDA UDI d6c5c120-1522-4062-b360-238dfa5c6390 35 fields · synced Jun 8, 2026