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One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ESWT-S-FHC-01 Model 10 Strips/Kit
by Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd.
Identity
- Trade Name
- One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay) EUDAMED
- Device Name
- One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay) EUDAMED
- Model / Reference
- 10 Strips/Kit EUDAMEDESWT-S-FHC-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975228760187 EUDAMED
- Basic UDI-DI
- B-06975228760187 EUDAMED
- EMDN Code
- W0102050205 TOTAL HUMAN CHORIONIC GONADOTROPIN EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay) by Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd. — Class IVD…
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-06975228760187 | Class IVD devices for self-testing | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000037568
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED f03d5553-a265-440a-8358-ab398cecf8b2 61 fields · synced Oct 6, 2026