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Sex hormone binding globulin (SHBG) Test Kit (Fluorescence Immunochromatographi…
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- Sex hormone binding globulin (SHBG) Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-K90411-045PK EUDAMED
- Basic UDI-DI
- B-K90411-045PK EUDAMED
- EMDN Code
- W0102050109 SEX HORMONE BINDING GLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sex hormone binding globulin (SHBG) Test Kit (Fluorescence Immunochromatographi… by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed…
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-K90411-045PK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 4e89cfb3-9116-4e10-8338-688f6a41764c 61 fields · synced Jul 8, 2026