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Macroduct Advanced Strap Set, Qty 180
EUDAMEDFDA UDIClass I (EU MDR)
Ref SS-270Model Macroduct Advanced Strap Set
Identity
- Trade Name
- Macroduct Advanced Strap Set, Qty 180 EUDAMEDMacroduct® Advanced Strap Set, Qty 180 FDA UDI
- Generic Name
- Sweat-induction iontophoresis system FDA UDI
- Device Name
- For use with Macroduct Advanced Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosis of Cystic Fibrosis. FDA UDI
- Model / Reference
- Macroduct Advanced Strap Set EUDAMEDSS-270 EUDAMEDFDA UDI
- Description
- For use with Macroduct Advanced Sweat Collection System to attach electrodes and collectors used to induce and collect sweat for diagnosis of Cystic Fibrosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540300356 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540MacroAdvStrpYS 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 I 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Macroduct Advanced Strap Set, Qty 180 by Elitechgroup Inc. — Class I — 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 | 3661540MacroAdvStrpYS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 ca3b90a3-0fb5-449a-97d0-747f601453d5 61 fields · synced Jun 18, 2026
- FDA UDI cf890d00-c763-4c8f-adf9-465c582775f2 35 fields · synced May 30, 2026