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Saliva Pregnancy Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref ICA2235Model 1 Test/Kit
Identity
- Device Name
- Saliva Pregnancy Test Kit EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMEDICA2235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565516 EUDAMED
- Basic UDI-DI
- B-06974541565516 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
The Saliva Pregnancy Test Kit is a user-friendly, point-of-care pregnancy test device that provides accurate results in just a few minutes. This device uses a small sample of saliva to detect the presence of human chorionic gonadotropin (hCG), a hormone produced during pregnancy.
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-06974541565516 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED cd58f307-2d0d-4057-9347-867e35a5281e 61 fields · synced Jul 26, 2026