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Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref 3021066Model 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit
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
- 1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit EUDAMED3021066 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794589514 EUDAMED
- Basic UDI-DI
- 69257945W0102050109R0NV EUDAMED
- EMDN Code
- W0102050109 SEX HORMONE BINDING GLOBULIN EUDAMED
Classification
- Device Class
- Class 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 B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69257945W0102050109R0NV | Class B | 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 cd2439fd-b932-4a06-b0a7-f235a1937aac 61 fields · synced Jun 19, 2026