← Back to catalogue

ri-former® diagnostic station with mobile base, 2 handels, 3, 5 / 120V

FDA UDI

Class II (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name
ri-former® diagnostic station with mobile base, 2 handels, 3,5 / 120V 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
3653-500 FDA UDI
Description
Diagnostic stations for diagnostic ENT instrument heads for non-invasive diagnosis. FDA UDI

Identifiers

Catalog Number
3653-500 FDA UDI
Primary DI / UDI-DI
04045396189232 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

ri-former® diagnostic station with mobile base, 2 handels, 3, 5 / 120V by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Rudolf Riester GmbH & Co. KG

Sources (1)

  • FDA UDI 4be05218-9151-4e15-b2af-402a49f00211 35 fields · synced May 30, 2026