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Macroduct Advanced Electrode Cable Assembly
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC-203Model Macroduct Advanced Sweat Collection System
Identity
- Trade Name
- Macroduct Advanced Electrode Cable Assembly EUDAMEDFDA UDI
- Generic Name
- Sweat-induction iontophoresis system FDA UDI
- Device Name
- The electrode cable assembly connects to the Macroduct Advanced inducer at the electrode connector on the top panel. Both electrodes, one red for the anode (positive) and one black for the cathode (negative), have a stainless-steel disc as the electrode plate. In the center of each electrode is a pin for detecting the Pilogel disc. The electrodes provide current from the device through the Pilogel discs to the patient skin during iontophoresis. FDA UDI
- Model / Reference
- Macroduct Advanced Sweat Collection System EUDAMEDAC-203 EUDAMEDFDA UDI
- Description
- The electrode cable assembly connects to the Macroduct Advanced inducer at the electrode connector on the top panel. Both electrodes, one red for the anode (positive) and one black for the cathode (negative), have a stainless-steel disc as the electrode plate. In the center of each electrode is a pin for detecting the Pilogel disc. The electrodes provide current from the device through the Pilogel discs to the patient skin during iontophoresis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540300370 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540MacroAdvInducerS5 EUDAMED
- 510(k) Number
- K180627 FDA UDI
- FDA Product Code
- KTB FDA UDI
- EMDN Code
- Z12080408 SWEAT TEST STIMULATORS EUDAMED
- GMDN Term
- Sweat-induction iontophoresis system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Macroduct Advanced Electrode Cable Assembly by Elitechgroup Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661540MacroAdvInducerS5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 7b989e3d-5735-4fe1-9855-48310d78d59a 61 fields · synced Jun 18, 2026
- FDA UDI 7ad48b5b-0fc8-4e2f-8f3d-7cc59ee2278e 35 fields · synced May 29, 2026