Identity
- Trade Name
- Sweat-Chek™ Sweat Conductivity Analyzer FDA UDI
- Generic Name
- Sweat conductivity analyser IVD FDA UDI
- Model / Reference
- Model 3120 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540303395 FDA UDI
- 510(k) Number
- K863395 FDA UDI
- FDA Product Code
- CGZ FDA UDI
- GMDN Term
- Sweat conductivity analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Sweat conductivity analyser IVD
Sweat-Chek™ Sweat Conductivity Analyzer by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sweat conductivity analyser IVD.
- Take-up Tubes, 14 inch, Qty 100 — ELITECHGROUP INC. · Class II
Cleared under the same submission
K863395 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 8a4e9d78-ddd1-48fe-9954-227457c893b3 34 fields · synced May 29, 2026