Identity
- Trade Name
- Sweat Controls, L1, L2, L3 EUDAMEDSweat Controls, L1, L2, L3, 12 ea., 36x0.75mL FDA UDI
- Generic Name
- Chloride (Cl-) IVD, control FDA UDI
- Device Name
- Sweat Controls; L1,L2,L3 EUDAMEDELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of validating the measurement of conductivity , osmolality, or chloride in patient samples. FDA UDI
- Model / Reference
- SS-150 EUDAMEDFDA UDI
- Description
- ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of validating the measurement of conductivity , osmolality, or chloride in patient samples. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540304361 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661540304361 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0101050204 ELECTROLYTE CONTROLS EUDAMED
- GMDN Term
- Chloride (Cl-) IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sweat Controls, L1, L2, L3 by Elitechgroup Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-03661540304361 | 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 794b5297-b2f9-4448-bcf0-68e0b696db8d 61 fields · synced Jul 13, 2026
- FDA UDI 35947a09-66d3-4b1c-a4fa-baff43502b52 34 fields · synced May 30, 2026