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Total Iron-Binding Capacity Reagent Kit (ferene Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3021737Model R1:2×50mL, R2:1×20mL, R3:2×50mL, R4:1×20mL
Identity
- Trade Name
- TOTAL IRON-BINDING CAPACITY REAGENT KIT (FERENE METHOD) EUDAMED
- Device Name
- TOTAL IRON-BINDING CAPACITY REAGENT KIT (FERENE METHOD) EUDAMED
- Model / Reference
- R1:2×50mL, R2:1×20mL, R3:2×50mL, R4:1×20mL EUDAMED3021737 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794593894 EUDAMED
- Basic UDI-DI
- B-06925794593894 EUDAMED
- EMDN Code
- W01010217 IRON BINDING CAPACITY - TOTAL (CC) 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
Total Iron-Binding Capacity Reagent Kit (ferene 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-06925794593894 | 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 (1)
- EUDAMED d310ca71-050d-41cf-b0af-91efdc7fcce9 61 fields · synced Jul 12, 2026