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Easy @ Home Pregnancy Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref EZW1-MN-5Ref EZM1-H3Ref EZW1-S-20
Identity
- Trade Name
- Easy @ Home Pregnancy Test EUDAMEDEasy@Home Pregnancy Test EUDAMED
- Device Name
- Easy@Home Pregnancy Test EUDAMEDEasy @ Home Pregnancy Test EUDAMED
- Model / Reference
- EZW1-MN-5 EUDAMEDEZM1-H3 EUDAMEDEZW1-S-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EZW1-MN-5FW EUDAMEDD-EZM1-H3YP EUDAMEDD-EZW1-S-20CD EUDAMED
- Basic UDI-DI
- B-EZW1-MN-5FW EUDAMEDB-EZM1-H3YP EUDAMEDB-EZW1-S-20CD EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Easy @ Home Pregnancy Test by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD devices for self-testing — IVDD — listed in EUDAMED
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-EZW1-MN-5FW | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 038fd440-2b6d-43a7-bb3f-36b44933e584 61 fields · synced Oct 6, 2026
- EUDAMED 8719cba2-cc97-46ab-9e51-7989ef5a1a6f 61 fields · synced May 18, 2026
- EUDAMED 1e4df39e-5332-4041-8781-683e0fa1aea9 61 fields · synced May 18, 2026