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Estradiol Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013801Model 50Tests/KitRef 3008731Model 100Tests/KitRef 3013802Model 2×50Tests/Kit
Identity
- Trade Name
- Estradiol Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Estradiol Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50Tests/Kit EUDAMED3013801 EUDAMED100Tests/Kit EUDAMED3008731 EUDAMED2×50Tests/Kit EUDAMED3013802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794520135 EUDAMED06925794511782 EUDAMED06942202224119 EUDAMED
- Basic UDI-DI
- B-06925794520135 EUDAMEDB-06925794511782 EUDAMEDB-06942202224119 EUDAMED
- EMDN Code
- W0102050103 ESTRADIOL 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
Estradiol 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-06925794520135 | 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 7b441c26-5fe3-46ce-9462-feff3afa79aa 61 fields · synced Jul 16, 2026
- EUDAMED 3fe808d1-abbc-4042-bbdb-6913bc9eac95 61 fields · synced May 17, 2026
- EUDAMED e93c3cce-b324-46cd-8ff5-72f6cea2dd91 61 fields · synced May 18, 2026