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Chloride Reagent Kit (thiocyanate Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3001678Model R: 4x50mL,Calibration sample: 2mLRef 3000847Model R: 5x50ml,Calibration sample: 2mLRef 3021201Model R: 5x50mL, Calibration sample: 2mL
Identity
- Trade Name
- CHLORIDE REAGENT KIT (THIOCYANATE METHOD) EUDAMED
- Device Name
- CHLORIDE REAGENT KIT (THIOCYANATE METHOD) EUDAMED
- Model / Reference
- R: 4x50mL,Calibration sample: 2mL EUDAMED3001678 EUDAMEDR: 5x50ml,Calibration sample: 2mL EUDAMED3000847 EUDAMEDR: 5x50mL, Calibration sample: 2mL EUDAMED3021201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260384 EUDAMED06942202246876 EUDAMED06942202260391 EUDAMED
- Basic UDI-DI
- B-06942202260384 EUDAMEDB-06942202246876 EUDAMEDB-06942202260391 EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Chloride Reagent Kit (thiocyanate Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06942202260384 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 330e7e67-5912-46f9-b0b9-3f5054bdcfb2 61 fields · synced Jul 11, 2026
- EUDAMED 413ef885-6bc5-41ae-8850-aafc2b6e26c3 61 fields · synced May 18, 2026
- EUDAMED c3655278-543b-4b83-8816-9efd53132c4b 61 fields · synced Jun 18, 2026