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SHBG (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320509002Model 2×50TRef 0320509004Model 2×100TRef 0320509003Model 100 TRef 0320509001Model 50T
Identity
- Trade Name
- SHBG (eCLIA) EUDAMED
- Device Name
- SHBG (eCLIA) EUDAMED
- Model / Reference
- 2×50T EUDAMED0320509002 EUDAMED2×100T EUDAMED0320509004 EUDAMED100 T EUDAMED0320509003 EUDAMED50T EUDAMED0320509001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063706 EUDAMED06975984063720 EUDAMED06975984063713 EUDAMED06975984063690 EUDAMED
- Basic UDI-DI
- B-06975984063706 EUDAMEDB-06975984063720 EUDAMEDB-06975984063713 EUDAMEDB-06975984063690 EUDAMED
- EMDN Code
- W0102050109 SEX HORMONE BINDING GLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
SHBG (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975984063706 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (4)
- EUDAMED f9f68c3a-49d7-4be4-a804-99e038358d1b 61 fields · synced Jul 22, 2026
- EUDAMED e786734d-ab90-4443-8ad0-cd787a849e15 61 fields · synced May 17, 2026
- EUDAMED 2fbe0205-24a4-4475-aac0-01de04a3f203 61 fields · synced May 17, 2026
- EUDAMED e16f4023-7f5e-4455-badc-15bd361d4102 61 fields · synced May 18, 2026