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Total Iron Chromazurol B Single Reagent
EUDAMEDClass IVD General (EU MDR)
Ref D-628 002Ref D-628 003Ref D-628 001Ref D-628 005
Identity
- Trade Name
- Total Iron Chromazurol B Single Reagent EUDAMED
- Device Name
- Total Iron Chromazurol B Single Reagent EUDAMED
- Model / Reference
- D-628 002 EUDAMEDD-628 003 EUDAMEDD-628 001 EUDAMEDD-628 005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182712846 EUDAMED62230182712914 EUDAMED62230182712778 EUDAMED62230182713140 EUDAMED
- Basic UDI-DI
- B-62230182712846 EUDAMEDB-62230182712914 EUDAMEDB-62230182712778 EUDAMEDB-62230182713140 EUDAMED
- EMDN Code
- W01010216 IRON (CC) 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
Total Iron Chromazurol B 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-62230182712846 | 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 (4)
- EUDAMED ad205a90-e0bd-4aa7-b790-973724ef04e3 61 fields · synced Aug 2, 2026
- EUDAMED ac1bbd59-eba6-4f80-ae22-d2053bcd4334 61 fields · synced May 18, 2026
- EUDAMED 00c13d08-880b-4fcc-b859-70c5b069eefc 61 fields · synced May 18, 2026
- EUDAMED 81d3f76b-1d1f-40ab-aa64-1f4e178a1dc5 61 fields · synced May 19, 2026