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Extension module, 1 handle, ri-former®

FDA UDI

Class II (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name
Extension module, 1 handle, ri-former® FDA UDI
Generic Name
ENT examination/treatment system FDA UDI
Device Name
Diagnostic stations for diagnostic ENT instrument heads for non-invasive diagnosis. FDA UDI
Model / Reference
300 FDA UDI
Description
Diagnostic stations for diagnostic ENT instrument heads for non-invasive diagnosis. FDA UDI

Identifiers

Catalog Number
300 FDA UDI
Primary DI / UDI-DI
04045396126879 FDA UDI
510(k) Number
K950914 FDA UDI
FDA Product Code
HLJ FDA UDI
GMDN Term
ENT examination/treatment system 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: ENT examination/treatment system

Extension module, 1 handle, ri-former® by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT examination/treatment system.

Cleared under the same submission

K950914 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 7e5cda92-7fb9-44ba-93a9-97c938ad6c65 35 fields · synced May 30, 2026