← Back to catalogue
Testosterone Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3008755Model 100Tests/KitRef 3013875Model 2×50Tests/Kit
Identity
- Trade Name
- Testosterone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Testosterone Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100Tests/Kit EUDAMED3008755 EUDAMED2×50Tests/Kit EUDAMED3013875 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794511867 EUDAMED06942202224133 EUDAMED
- Basic UDI-DI
- B-06925794511867 EUDAMEDB-06942202224133 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) 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
Testosterone 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-06925794511867 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b7aa4038-b159-40d2-8309-acb003d53fd9 61 fields · synced Jul 9, 2026
- EUDAMED d5858dcb-81ca-4006-be1e-cc2b73265e10 61 fields · synced May 17, 2026