← Back to catalogue

Phothera

FDA UDI

Class II (US FDA UDI)

by Hidrex GmbH

Identity

Trade Name
Phothera FDA UDI
Generic Name
Hyperhidrosis iontophoresis system FDA UDI
Device Name
Phothera Aquex Tap Water Iontophoresis Device Package (US) FDA UDI
Model / Reference
Aquex (HPRO10) FDA UDI
Description
Phothera Aquex Tap Water Iontophoresis Device Package (US) FDA UDI

Identifiers

Catalog Number
PHO1000K FDA UDI
Primary DI / UDI-DI
04250571300832 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

Phothera 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

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

Manufacturer

Manufacturer
Hidrex GmbH

Sources (1)

  • FDA UDI b7f2ed5d-7005-40dd-9421-806223cc88f0 35 fields · synced Jun 6, 2026