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The Fischer

FDA UDI

Class II (US FDA UDI)

by Saalmann medical GmbH & Co. KG

Identity

Trade Name
The Fischer FDA UDI
Generic Name
Hyperhidrosis iontophoresis system FDA UDI
Device Name
Tap Water Iontophoresis Device for Treatment of Hyperhidrosis (Hands and Feet) FDA UDI
Model / Reference
07-80-000-09 FDA UDI
Description
Tap Water Iontophoresis Device for Treatment of Hyperhidrosis (Hands and Feet) FDA UDI

Identifiers

Primary DI / UDI-DI
04260587510200 FDA UDI
510(k) Number
K191436 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

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

No

FDA UDI

Category: Hyperhidrosis iontophoresis system

The Fischer by Saalmann medical GmbH & Co. KG — 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
Saalmann medical GmbH & Co. KG

Sources (1)

  • FDA UDI 972650c9-3e5d-49ab-8f28-a7e09a4a4d87 35 fields · synced May 30, 2026