← Back to catalogue
One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ESWT-M-FHC-02Model 2 Midstreams/KitRef ESWT-C-FHC-03Model 3 Cassettes/KitRef ESWT-M-FHC-03Model 3 Midstreams/KitRef ESWT-M-FHC-05Model 10 Midstreams/KitRef ESWT-S-FHC-02Model 20 Strips/KitRef ESWT-M-FHC-01Model 1 Midstream/KitRef ESWT-C-FHC-04Model 5 Cassettes/KitRef ESWT-S-FHC-03Model 50 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
- 2 Midstreams/Kit EUDAMEDESWT-M-FHC-02 EUDAMED3 Cassettes/Kit EUDAMEDESWT-C-FHC-03 EUDAMED3 Midstreams/Kit EUDAMEDESWT-M-FHC-03 EUDAMED10 Midstreams/Kit EUDAMEDESWT-M-FHC-05 EUDAMED20 Strips/Kit EUDAMEDESWT-S-FHC-02 EUDAMED1 Midstream/Kit EUDAMEDESWT-M-FHC-01 EUDAMED5 Cassettes/Kit EUDAMEDESWT-C-FHC-04 EUDAMED50 Strips/Kit EUDAMEDESWT-S-FHC-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975228760071 EUDAMED06975228760132 EUDAMED06975228760088 EUDAMED06975228760101 EUDAMED06975228760170 EUDAMED06975228760194 EUDAMED06975228760149 EUDAMED06975228760163 EUDAMED
- Basic UDI-DI
- B-06975228760071 EUDAMEDB-06975228760132 EUDAMEDB-06975228760088 EUDAMEDB-06975228760101 EUDAMEDB-06975228760170 EUDAMEDB-06975228760194 EUDAMEDB-06975228760149 EUDAMEDB-06975228760163 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-06975228760071 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000037568
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (8)
- EUDAMED 3e2040d8-1089-4742-9101-d370a4507bb6 61 fields · synced Oct 8, 2026
- EUDAMED 07744f6c-e2d3-4ef9-a742-e4c731f069d8 61 fields · synced May 16, 2026
- EUDAMED 2f705130-b4eb-4386-b3dc-604285a7a303 61 fields · synced May 18, 2026
- EUDAMED 99ef71fa-7519-476b-8d54-f99affc78985 61 fields · synced May 18, 2026
- EUDAMED cf199b0b-78c5-4a93-8a09-b2e35401f494 61 fields · synced May 18, 2026
- EUDAMED dbc3996f-2c66-45af-8e63-34702937cd6b 61 fields · synced May 18, 2026
- EUDAMED c09a9989-a54d-41f1-8be6-5ded7ed67e22 61 fields · synced May 18, 2026
- EUDAMED 4f0e5cd4-0f1a-4f78-ae76-55224018e2d6 61 fields · synced May 18, 2026