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Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3021188Model R1: 4x40mL, R2: 2x40mL, Calibration sample: 5x0.5mL, Control: 2x0.5mLRef 3023227Ref 3021528
Identity
- Trade Name
- Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 4x40mL, R2: 2x40mL, Calibration sample: 5x0.5mL, Control: 2x0.5mL EUDAMED3021188 EUDAMED3023227 EUDAMED3021528 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259364 EUDAMED06942202213458 EUDAMED06925794593375 EUDAMED
- Basic UDI-DI
- B-06942202259364 EUDAMEDB-06942202213458 EUDAMEDB-06925794593375 EUDAMED
- EMDN Code
- W0102070102 FERRITIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202259364 | 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 44f80791-a9ca-43a3-bcc0-40c6e1072b52 61 fields · synced Jul 23, 2026
- EUDAMED b3036f36-f8da-4f62-85f1-072ee0e6eae1 61 fields · synced May 18, 2026
- EUDAMED ac77d0e6-061b-48a3-b5f6-91d55a90b8dc 61 fields · synced May 19, 2026