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Hidrex Usa

FDA UDI

Class II (US FDA UDI)

by Hidrex GmbH

Identity

Trade Name
HIDREX USA FDA UDI
Generic Name
Hyperhidrosis iontophoresis system FDA UDI
Device Name
HIDREX USA DP450 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug) FDA UDI
Model / Reference
DP450 Package HF AL FDA UDI
Description
HIDREX USA DP450 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug) FDA UDI

Identifiers

Catalog Number
ION17451US FDA UDI
Primary DI / UDI-DI
04250571300719 FDA UDI
FDA Product Code
EGJ FDA UDI
GMDN Term
Hyperhidrosis iontophoresis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5525 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hyperhidrosis iontophoresis system

Hidrex Usa by Hidrex GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hyperhidrosis iontophoresis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hidrex GmbH

Sources (1)

  • FDA UDI e92ed0e4-efe4-47ea-b341-c7ac4edce062 35 fields · synced May 30, 2026