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Ferritin Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3008779Model 100Tests/KitRef 3013911Model 50Tests/KitRef 3013736Model 2×50 tests/kit
Identity
- Trade Name
- Ferritin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Ferritin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100Tests/Kit EUDAMED3008779 EUDAMED50Tests/Kit EUDAMED3013911 EUDAMED2×50 tests/kit EUDAMED3013736 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794511942 EUDAMED06925794519603 EUDAMED06942202223945 EUDAMED
- Basic UDI-DI
- B-06925794511942 EUDAMEDB-06925794519603 EUDAMEDB-06942202223945 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 Detection Kit (Chemiluminescence Immunoassay) 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-06925794511942 | 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 d6a9044a-deb7-4d01-93b8-4add33ecac1b 61 fields · synced Jul 23, 2026
- EUDAMED 880b8cad-d9ca-4b69-ac04-95301de6ce27 61 fields · synced May 18, 2026
- EUDAMED 43021fa7-c55b-4b61-badc-76a82c68c00a 61 fields · synced May 19, 2026