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Chloride Single Reagent
EUDAMEDClass IVD General (EU MDR)
Ref D-620 004Ref D-620 003Ref D-620 002
Identity
- Trade Name
- Chloride Single Reagent EUDAMED
- Device Name
- Chloride Single Reagent EUDAMED
- Model / Reference
- D-620 004 EUDAMEDD-620 003 EUDAMEDD-620 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182711474 EUDAMED62230182711306 EUDAMED62230182711238 EUDAMED
- Basic UDI-DI
- B-62230182711474 EUDAMEDB-62230182711306 EUDAMEDB-62230182711238 EUDAMED
- EMDN Code
- W01010304 CHLORIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 Single Reagent by Kalians Corporation — 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-62230182711474 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED e0c25f7e-7e87-49b4-bd5e-68ea06111d3b 61 fields · synced Jul 17, 2026
- EUDAMED fea5822b-f20a-4428-9c59-bd91d0da08c0 61 fields · synced May 18, 2026
- EUDAMED 646a07e9-88b2-4f61-9fe8-812cd8b72647 61 fields · synced May 18, 2026