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Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3010697Model 100Tests/KitRef 3013889Model 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kitRef 3010677Model 50Tests/KitRef 3021081
Identity
- Trade Name
- Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100Tests/Kit EUDAMED3010697 EUDAMED1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED3013889 EUDAMED50Tests/Kit EUDAMED3010677 EUDAMED3021081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794518217 EUDAMED06925794588685 EUDAMED06925794518200 EUDAMED06925794589507 EUDAMED
- Basic UDI-DI
- B-06925794518217 EUDAMED69257945W0102050109R0NV EUDAMEDB-06925794518200 EUDAMED
- EMDN Code
- W0102050109 SEX HORMONE BINDING GLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B 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
New Device
No
EUDAMED
Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDR, IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06925794518217 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06925794518217 | 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 (4)
- EUDAMED 321d49b2-08a6-4ded-ae0b-2d364f0b9c4e 61 fields · synced Jul 23, 2026
- EUDAMED 0220cf01-92b2-4ea2-a6b5-eca11e3fd189 61 fields · synced May 18, 2026
- EUDAMED 8fbd2074-71dd-448d-b7f1-b0d336ca32b4 61 fields · synced May 18, 2026
- EUDAMED 040a0f3f-8e89-49bb-8eef-b7044c3d9177 61 fields · synced May 19, 2026