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ChloroChek® Chloridometer® Sweat Chloride Analyzer
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref Model 3400
Identity
- Trade Name
- ChloroChek® Chloridometer® Sweat Chloride Analyzer FDA UDI
- Generic Name
- Chloride coulometric titration analyser IVD, semi-automated FDA UDI
- Device Name
- ChloroChek® Chloridometer® Sweat Chloride Analyzer EUDAMEDThe ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. FDA UDI
- Model / Reference
- Model 3400 EUDAMEDFDA UDI
- Description
- The ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540304088 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661540304088 EUDAMED
- 510(k) Number
- K121823 FDA UDI
- FDA Product Code
- JFS FDA UDI
- EMDN Code
- W0201040203 CHLORIDE ANALYSERS EUDAMED
- GMDN Term
- Chloride coulometric titration analyser IVD, semi-automated FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1170 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
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ChloroChek® Chloridometer® Sweat Chloride Analyzer by Elitechgroup Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03661540304088 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 2756c694-df85-4826-a2e3-5021994c5ff7 61 fields · synced Jul 15, 2026
- FDA UDI 352969af-174c-4906-b6f8-b4a4d988de45 35 fields · synced May 30, 2026