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ChloroChek Standard Solution, 100 mmol/L
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref SS-251
Identity
- Trade Name
- ChloroChek Standard Solution, 100 mmol/L EUDAMEDChloroChek® Standard Solution, 100 mmol/L, 10x1mL FDA UDI
- Generic Name
- Chloride (Cl-) IVD, calibrator FDA UDI
- Device Name
- ChloroChek Standard Solution, 100 mmol/L EUDAMEDELITechGroup Inc CHLOROCHEK Standard Solution is an aqueous solution used to conditioning or check the performance of ChloroChek Chloridometer by qualified personnel. FDA UDI
- Model / Reference
- SS-251 EUDAMEDFDA UDI
- Description
- ELITechGroup Inc CHLOROCHEK Standard Solution is an aqueous solution used to conditioning or check the performance of ChloroChek Chloridometer by qualified personnel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540304101 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661540304101 EUDAMED
- 510(k) Number
- K121823 FDA UDI
- FDA Product Code
- JIS FDA UDI
- EMDN Code
- W0101050303 AQUEOUS STANDARDS (CC) EUDAMED
- GMDN Term
- Chloride (Cl-) IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
ChloroChek Standard Solution, 100 mmol/L 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-03661540304101 | 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 6718af96-209e-415f-8117-cd93621a4ec3 61 fields · synced Jun 18, 2026
- FDA UDI 151ad4ae-fdde-4119-af50-0ab999c63d6b 36 fields · synced May 29, 2026