Macroduct Advanced Sweat Collection System

FDA UDI

Class II (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name: Macroduct Advanced Sweat Collection System FDA UDI
Generic Name: Sweat-induction iontophoresis system FDA UDI
Device Name: The Macroduct Advanced Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis. FDA UDI
Model / Reference: Model 3710-Sys FDA UDI
Description: The Macroduct Advanced Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis. FDA UDI

Identifiers

Primary DI / UDI-DI: 03661540300400 FDA UDI
510(k) Number: K180627 FDA UDI
FDA Product Code: KTB FDA UDI
GMDN Term: Sweat-induction 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sweat-induction iontophoresis system

Macroduct Advanced Sweat Collection System by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sweat-induction iontophoresis system.

Q-Sweat — WR Medical Electronics Co. · Class II
Macroduct® Collection Strap, Large, Qty 1 — ELITECHGROUP INC. · Class II
Macroduct® Advanced Supply Kit, w/o Dye, Qty 6 — ELITECHGROUP INC. · Class II
Macroduct® Collection Strap, XLarge, Qty 1 — ELITECHGROUP INC. · Class II
Macroduct® Collector, Qty 1 — ELITECHGROUP INC. · Class II
Macroduct® Sweat Collection System — ELITECHGROUP INC. · Class II
Macroduct® Collection Strap, Small, Qty 1 — ELITECHGROUP INC. · Class II
Macroduct® Black Electrode Strap, Qty 1 — ELITECHGROUP INC. · Class II

Cleared under the same submission

K180627 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Elitechgroup Inc.

Sources (1)

FDA UDI 0931b7c0-059d-4967-b9ab-f180df2e3bef 34 fields · synced May 30, 2026